Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION March 9, 2026 Shenzhen Root Innovation Technology Co., Ltd. Haiyan Wen Compliance Engineer 2-201, Floor 2 Hasee Computer Bldg., # 2 Beier Rd. Bantian St., Longgang Shenzhen, Guangdong 518219 CHINA Re: K253934 Trade/Device Name: Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C) Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: December 9, 2025 Received: December 9, 2025 Dear Haiyan Wen: 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} K253934 - Haiyan Wen 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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 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 Management System Regulation (QMSR) (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 {2} K253934 - Haiyan Wen Page 3 Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See 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, Reginald K. Avery -S for 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} FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K253934 | | | Device Name Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C) | | | Indications for Use (Describe) The Momcozy Wearable Breast Pump (Model: BP380,BP380-A,BP380-B,BP380-C,M5,M5-A,M5-B,M5-C) is a powered breast pump intended to express milk from lactating women in order to 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." | | {4} K253934 Page 1 of 4 510(k) #:K253934 510(k) Summary Prepared on 2026-03-05 | Contact Details 807.92(a)(1) | 21 CFR | | --- | --- | | Applicant Name | Shenzhen Root Innovation Technology Co., Ltd. | | Applicant Address | #2-201, Floor 2 Hasee Computer Building, No. 2 Beier Rd, Bantian Street, Longgang, Shenzhen, 518129, China. | | Applicant Contact Telephone | 86-755-89698173 | | Applicant Contact | Mr. Haiyan Wen | | Applicant Contact Email | wendy.wen@rootglobal.net | | Device Name 807.92(a)(2) | | 21 CFR | | --- | --- | --- | | Device Trade Name | Momcozy Wearable Breast Pump (BP380,BP380-A,BP380-B,BP380-C,M5,M5-A,M5-B,M5-C) | | | Common Name | Powered breast pump | | | Regulation Name | Powered Breast Pump | | | Regulation Number | 21 CFR 884.5160 | | | Product Code(s) | HGX (Pump, Breast, Powered) | | | Regulatory Class | II | | | Legally Marketed Predicate Device 807.92(a)(3) | | 21 CFR | | --- | --- | --- | | Predicate # | Predicate Device Trade Name | Product Code | | K251394 | Momcozy Wearable Breast Pump (BP223) | HGX | | The predicate device has not been subject to a design-related recall. | | | ## Device Description 21 CFR 807.92(a)(4) The Momcozy Wearable Breast Pump is an electrically powered wearable breast pump. There are two product series: Momcozy Wearable Breast Pump M5 series (M5,M5-A,M5-B,M5-C) and Momcozy Wearable Breast Pump BP380 series (BP380,BP380-A,BP380-B,BP380-C). The differences between M5 series and BP380 series are as follows: 1) BP380 series is equipped with Bluetooth functionality, and can be wirelessly operated via Bluetooth connection to a mobile device 2) M5 series disables the Bluetooth functionality. The differences between each model in a series is the color of the main unit. The device is intended to be used by lactating women to express and collect milk from their breast. The device is not sterile. 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 collector. The device includes stimulation mode, expression mode, and mixed mode. In stimulation mode, the breast pump begins with a quick and short sucking pattern to get your milk to start flowing. In expression mode, the breast pump begins with a slow and long sucking pattern for milk expression, sucking more deeply and more slowly. In mixed mode, the breast {5} K253934 Page 2 of 4 pump begins with a quick and short sucking pattern, followed by a slow and long sucking pattern. The device uses a diaphragm-type vacuum pump driven by a microprocessor. The microprocessor provides control over vacuum pressure and cycle speed. The pump remembers the mode and suction level settings. When restarted, it will resume with the same mode and suction level as when it was last turned off. Each mode's suction level setting is also remembered individually and remains consistent during future use. The device can be operated in single/double pumping modes. 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 motor unit operates on a rechargeable battery. The rechargeable battery can be charged from the external power adapter (not included in this device) through the provided charging cable. The user interface consists of buttons and LED display in which the user switches between modes and controls the vacuum pressure. The BP380 series(BP380,BP380-A,BP380-B,BP380-C) can be wirelessly operated via Bluetooth connection to a mobile device. By using app, users can either select one of three preset operating modes. Available modes include Stimulation, Expression and Mixed. The devices includes a milk collection set that consists of the following: double-sealed flange, flange insert, diaphragm assembly, duckbill valve assembly, milk collector and main unit pump motor. Each component can be purchased separately by the user if needed. The materials of the milk collection set comply with U.S. food-contact safety testing requirements **Indications for Use** **21CFR807.92(a)(5)** The Momcozy Wearable Breast Pump (Model: BP380,BP380-A,BP380-B,BP380-C,M5,M5-A,M5-B,M5-C) is a powered breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user. **Comparison of Intended Use and Technological Characteristics with the Predicate Device** **21 CFR 807.92(a)(5), 21 CFR 807.92(a)(6)** The table below compares the intended use and technological characteristics of the subject and predicate device. | Element of Comparison | Subject Device | Predicate Device | Conclusion | | --- | --- | --- | --- | | Regulation No. | 884.5160 | 884.5160 | Same | | Product Code | HGX | HGX | Same | | Classification | Class II | Class II | Same | | Patient Population | Lactating Women | Lactating women | Same | | Environment of Use | Home Healthcare Environment | Home Healthcare Environment | Same | | Indications for Use (IFU) | The Momcozy Wearable Breast Pump (model: BP380 BP380-A BP380-B BP380-C ; M5 M5-A M5-B M5-C) is a powered breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user. | The Momcozy Wearable Breast Pump (model: BP223) is a powered breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user. | Same | | Pump Options | Single and Double | Single and Double | Same | | Cycling | Microcontroller | Microcontroller | Same | {6} K253934 Page 3 of 4 | Element of Comparison | Subject Device | Predicate Device | Conclusion | | --- | --- | --- | --- | | Control | | | | | BackFlow Protection | Yes | Yes | Same | | Suction Modes | Stimulation Mode, Expression Mode, Mixed Mode | Stimulation Mode, Expression Mode, Mixed Mode | Same | | Suction Levels | 9 | 15 | Different. Differences in pumping suction level number do not raise different questions of safety and effectiveness | | Adjustable suction levels | Yes | Yes | Same | | Vacuum Range (mmHg) | Stimulation mode: -75~-145 Expression mode: -120~-285 Mixed mode: -75~-285 (Error : ±30mmHg) | Stimulation mode: -65~-174 Expression mode: -109~-305 Mixed mode: -65~-305 (Error : ±30 mmHg, except -305 which is +30 mmHg and -10 mmHg) | Different. 1. The minor differences in pumping suction range between subject device and primary predicate device do not raise different questions of safety and effectiveness. 2. the Error setting between subject device and reference Device is similar and it does not do not raise different questions of safety and effectiveness. | | Cycle Speed (cycle/min) | Stimulation mode: 50~120(±2) Expression mode: 23~57(±2) Mixed mode: 40~100(±2) | Stimulation mode: 54~90(±5) Expression mode: 25~60(±5) Mixed mode: 46~84(±5) | Different. Differences in available cycle speed do not raise different questions of safety and effectiveness. | | Power Supply | 3.7V Li-ion Battery | 3.7V Li-ion Battery | Same | | Indicators | LED | LED | Same | | OTC or Rx | OTC | OTC | Same | | Mobile Application | Bluetooth connect, IOS and Android App | Bluetooth connect, IOS and Android App | Same | The subject and predicate device have similar indications for use and have the same intended use (i.e. to express milk from lactating women in order to collect milk from their breasts). The subject and predicate devices have similar technological features, including wearable operation, power supply, cycling control and user interface. However, as shown in the table above, there are technological differences between the subject and predicate device, including different overall vacuum/cycle specifications and available suction mode and 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. ## Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b) ### 1) Biocompatibility Testing The biocompatibility evaluation for the patient-contacting components was conducted 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", as follows: - ISO 10993-5:2009, Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity - ISO 10993-10:2021, Biological evaluation of medical devices – Part 10: Tests for skin sensitization {7} K253934 Page 4 of 4 - ISO 10993-23:2021, Biological evaluation of medical devices – Part 23: Tests for skin irritation ## 2) Electrical Safety and EMC Electrical safety and EMC testing was performed per the following standards: - ANSI AAMI ES60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. - IEC 60601-1-11 Medical Electrical Equipment – Part 1: General Requirements for Basic. - Safety and Essential Performance – Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment. - ANSI AAMI ES 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: electromagnetic compatibility. - IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability - IEC 62133-2 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. ## 3) Software Verification and Validation Software verification and validation consistent with a basic level of concern per the FDA guidance document “Content of Premarket Submissions for Device Software Functions” dated June 2023. 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. ## 4) Additional Non-Clinical Testing - Suction strength and cycle speed - Back flow testing - Battery capacity and Battery Indicator testing - Device life testing ## Conclusions 21 CFR 807.92(b) The results of the performance testing described above demonstrate that Momcozy Wearable Breast Pump (BP380,BP380-A,BP380-B,BP380-C,M5,M5-A,M5-B,M5-C) is as safe and effective as the predicate devices and supports a determination of substantial equivalence to the predicate devices.