← Product Code [HGX](/productcode/HGX) · K250070 # Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) (K250070) _Shenzhen Changkun Technology Co., Ltd. · HGX · Jun 26, 2026 · Obstetrics/Gynecology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K250070 ## Device Facts - **Applicant:** Shenzhen Changkun Technology Co., Ltd. - **Product Code:** [HGX](/productcode/HGX.md) - **Decision Date:** Jun 26, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 884.5160 - **Device Class:** Class 2 - **Review Panel:** Obstetrics/Gynecology - **Attributes:** Therapeutic ## Indications for Use The Electric Breast Pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) is intended to be used by lactating women to express and collect milk from their breasts. The device is intended for a single user. ## Device Story Wearable powered breast pump; uses diaphragm-type vacuum pump controlled by microprocessor. Input: user selection of modes/suction levels via buttons/LED interface. Transformation: microprocessor regulates vacuum pressure and cycle speed to stimulate lactation and extract milk. Output: expressed milk collected in container; device displays mode, time, and battery status. Used in home environment by lactating women. Benefits: facilitates milk expression for single users. Powered by 3.7V rechargeable Li-ion battery. ## Clinical Evidence Bench testing only. Testing included biocompatibility (ISO 10993-1), electrical safety/EMC (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11), battery safety (IEC 62133-2), software verification/validation, vacuum pressure/cycle frequency, battery capacity, backflow protection, and use-life testing. All tests met pre-defined acceptance criteria. ## Technological Characteristics Diaphragm-type vacuum pump; microprocessor-controlled. Materials: PP (milk collector), silicone (shield), ABS (host). Power: 3.7V rechargeable Li-ion battery. Modes: Massage, Pumping, Inverter Pumping, Automatic. Connectivity: None. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 62133-2, 21 CFR 177 (milk-contacting materials). ## Regulatory Identification A powered breast pump in an electrically powered suction device used to express milk from the breast. ## Predicate Devices - Electric breast pump (Model MY-373) ([K231595](/device/K231595.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} **FDA** **U.S. FOOD & DRUG** ADMINISTRATION June 26, 2026 Shenzhen Changkun Technology Co., Ltd. % Reanny Wang General Manager Shenzhen Reanny Medical Devices Mgmt Consulting Co., Ltd Room 1509, Jingting Building, Dongzhou Community Guangming Street, Guangming District Shenzhen, Guangdong 518122 CHINA Re: K250070 Trade/Device Name: Electric Breast Pump (MY-375,MY-376,MY-378, MY-379,MY-380,V3) Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: December 8, 2025 Received: December 8, 2025 Dear Reanny Wang: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: The Center for Devices and Radiological Health (CDRH) does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K250070 - Reanny Wang Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled 'Deciding When to Submit a 510(k) for a Change to an Existing Device' (https://www.fda.gov/media/99812/download) and 'Deciding When to Submit a 510(k) for a Software Change to an Existing Device' (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ('UDI Rule'). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, 'Misbranding by reference to premarket notification' (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See {2} K250070 - Reanny Wang Page 3 the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology, and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. # Indications for Use 510(k) Number (if known) K250070 Device Name Electric Breast Pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) Indications for Use (Describe) The Electric Breast Pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) is intended to be used by lactating women to express and collect milk from their breasts. The device is intended for a single user. Type of Use (Select one or both, as applicable) ☐ Prescription Use (Part 21 CFR 801 Subpart D) ☑ Over-The-Counter Use (21 CFR 801 Subpart C) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 441-6740 EF {4} 510(k) Summary K250070 Page 1 of 6 # 510(k) Summary-K250070 ## 1. Submitter Information Company Name: Shenzhen Changkun Technology Co., Ltd. Street Address: 101,Building 1, 15# Xiusheng 2nd Road , Xiuxin Community, Kengzi Street, Pingshan District, Shenzhen city, Guangdong Province, 518122, P.R. China Contact Person: Wang Qingpeng Contact Title: General Manager Contact Email: 605984618@qq.com ## 2. Consultant's Information Company Name: Shenzhen Reanny Medical Devices Management Consulting Co.,Ltd. Street Address: Room 1509, Jingting Building, Dongzhou Community, Guangming Street, Guangming District, Shenzhen, China Contact Person: Reanny Wang Contact Email: reanny@reanny.com **3.Date prepared:** June 24, 2026 ## 4. Subject Device Information Device Trade Name: Electric Breast Pump (MY-375, MY-376, MY-378, MY-379, MY-380, V3) Common Name: Powered Breast Pump Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Product Code: HGX (Pump, Breast, Powered) Classification Panel: Obstetrics/Gynecology Regulatory Class: Class II ## 5. Predicate Device Information Device Name: Electric breast pump (Model MY-373) 510(k) Number: K231595 The predicate device has not been subject to a design related recall. Page 1 of 7 {5} K250070 510(k) Summary Page 2 of 6 ## 6. Device Description The Electric Breast Pump is a wearable powered breast pump intended to be used by lactating women to express and collect milk from their breast. The breast pump stimulates lactation and extracts milk from the breasts by creating a seal around the nipple and applying and releasing suction to the breast. The milk is collected in a milk collection container. The device is not sterile and is meant for repeated use by a single user. The device uses a diaphragm-type vacuum pump controlled by a microprocessor. The microprocessor provides control over vacuum pressure and cycle speed. The device provides for single suction. The user interface consists of buttons and LED display allowing the user to switch between modes and levels of vacuum pressure and displaying the information of current working mode, operating time and battery status. The device includes six models - MY-375, MY-376, MY-378, MY-379, MY-380, V3, and these models have same working principle and similar technological characteristics. These models differ in terms of their appearance, milk collection set components, and user interface. All models include four modes of operation Massage mode, Pumping mode, Inverter Pumping mode, and Automatic mode. Massage mode, Pumping mode, and Automatic mode have twelve suction levels each, while the Inverter Pumping mode has six distinct suction levels. To prevent milk from flowing into the vacuum system, the milk collection set includes a diaphragm that physically separates the milk-contacting pathway from the vacuum system. The valve between the milk collector and linker prevents the milk in the bottle from flowing back to the Linker during suction. The motor unit operates on a 3.7V rechargeable lithium battery. The rechargeable battery can be charged from the external power adapter (not included in this device) through the provided charging cable. Milk contacting components of the device are compliant with 21 CFR 177. ## 7. Indications for Use The Electric Breast Pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) is intended to be used by lactating women to express and collect milk from their breasts. The device is intended for a single user. ## 8. Comparison of Intended Use and Technological Characteristics with the Predicate Device Page 2 of 6 {6} K250070 510(k) Summary Page 3 of 6 The table below compares the intended use and technological characteristics of the subject and predicate device. Table 1: Comparison Table for Subject and Predicate Devices | Device | Subject device (K250070) | Predicate device (K231595) | Comparison | | --- | --- | --- | --- | | Product name | Electric Breast Pump (MY-375,MY-376, MY-378, MY-379, MY-380, V3) | Electric breast pump (Model:MY-373) | NA | | Product Code | HGX | HGX | Same | | Regulation Number | 21 CFR 884.5160 | 21 CFR 884.5160 | Same | | Regulatory Class | Class II | Class II | Same | | Single user | Yes | Yes | Same | | Patient Population | Lactating Women | Lactating Women | Same | | Use Environment | Home Healthcare Environment | Home Healthcare Environment | Same | | Indications for Use (IFU) | The Electric Breast Pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) is intended to be used by lactating women to express and collect milk from their breasts. The device is intended for a single user. | The Electric Breast Pump is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user. | Similar | | OTC or Rx | OTC | OTC | Same | | Pump Options | Single pumping | Single pumping | Same | | Provided non-sterile | Yes | Yes | Same | | Media Separation (Backflow Protection) | Yes | Yes | Same | | Suction Modes | Massage Mode Pumping Mode Inverter pumping mode Automatic mode | Lactation Mode Pumping mode Inverter pumping mode Sucking mode | Similar | | Adjustable suction levels | Yes | Yes | Same | | Vacuum range(mmHg) | Massage mode: 15 to 140 Pumping mode: 68 to 292 Inverter Pumping mode: 20/150 to 80/150 Automatic mode: 23 to 287 | Lactation mode: 30 to 225 Pumping mode: 80 to 292 Inverter Pumping mode: 60 to 282 Sucking mode: 55 to 270 | Different | | Cycle Speed (cycles/minute) | Massage mode: 87 to 115 Pumping mode: 33 to 105 Inverter Pumping mode: 87 to 115 Automatic mode: 33 to 113 | Lactation mode: 36 to 85 Pumping mode:26 to 56 Inverter Pumping mode:32 to 78 Sucking mode: 24 to 47 | Different | | Maximum Suction | 297 mm Hg | 297 mmHg | Same | | Controls | MY-375, MY-378, V3 | Power button, Mode button, Gear minus button, Gear plus button | Similar | Page 3 of 6 {7} K250070 510(k) Summary Page 4 of 6 | Device | Subject device (K250070) | | Predicate device (K231595) | Comparison | | --- | --- | --- | --- | --- | | | On/Off/Mode button, Gear Shift(+), Gear Shift(-) | Power/Pause button, Mode button, Gear Shift(+), Gear Shift(-) | | | | Indicators | LED indicators | | LED indicators | Same | | Power Supply | DC 5V 1A 3.7V 1200mAh Rechargeable Li-ion battery | | DC 5V 1A 3.7V 1200mAh Rechargeable Li-ion battery | same | | Pump type | Diaphragm | | Diaphragm | Same | | Materials | Milk collector: PP (Polypropylene), Silicone shield: Silicone, Host: ABS | | Milk collector: PP (Polypropylene), Silicone shield: Silicone, Host: ABS | Same | The subject and predicate device have similar Indications for Use statements and same intended use (i.e., for the collection of breast milk from the breasts of lactating women). As shown in the table above, there are technological differences between the subject and predicate device, including different vacuum/cycle specifications and available suction levels in each mode. The different technological characteristics of the subject device, as compared to the predicate device, do not raise different questions of safety and effectiveness. ### 9. Summary of Non-Clinical Performance Testing Non-clinical tests were conducted to verify that the subject devices met all design specifications to be considered substantially equivalent to the predicate device: #### 9.1. Biocompatibility Testing The biocompatibility evaluation for the patient-contacting components was leveraged from the predicate device and was in accordance with the 2023 FDA guidance document “Use of International Standard ISO 10993-1, “Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process””. #### 9.2. Electrical Safety and EMC Electrical safety and EMC testing was performed per the following standards: - IEC 60601-1-2:2014 +A1:2020 Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance –Collateral standard: electromagnetic compatibility Page 4 of 6 {8} 510(k) Summary K250070 Page 5 of 6 - IEC 60601-1:2005/AMD2:2020, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, with US National deviations - IEC 60601-1-11:2015/AMD1:2020, Medical Electrical Equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral Standard: Requirements for medical electrical equipment and medical electrical equipment and medical electrical systems used in the home healthcare environment, with US National deviations - IEC 62133-2:2017- Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems # 9.3. Software Verification and Validation Software verification and validation consistent with basic documentation level per the 2023 FDA guidance document "Content of Premarket Submissions for Device Software Functions". System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met, and all software hazards have been mitigated to acceptable risk levels. # 9.4. Non-Clinical Performance Testing Additional non-clinical performance tests were conducted to demonstrate that the device meets its design requirements and performs as intended throughout its proposed service-life: - Vacuum pressure and cycle frequency test for all modes and levels of device operation. - Battery capacity and battery indicator accuracy test to demonstrate that the battery and battery indicator function as intended during its stated use-life. - Backflow protection testing to ensure no liquid will backflow into the air inlet - Use-life testing The subject device met the pre-defined acceptance criteria for all the above tests. # 10. Conclusion The results of the performance testing described above demonstrate that Electric Breast Pump (MY-375, MY-376, MY-378, MY-379, MY-380, V3) is as safe and effective as the Page 5 of 6 {9} K250070 510(k) Summary Page 6 of 6 predicate device and supports a determination of substantial equivalence to the predicate device. Page 6 of 6 --- **Source:** [https://fda-staging.innolitics.com/device/K250070](https://fda-staging.innolitics.com/device/K250070) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com