Oxygen Concentrator (J5A)

{0} FDA U.S. FOOD &amp; DRUG ADMINISTRATION November 21, 2025 Foshan KYCARE Medical Equipment Co., Ltd. % Jarvis Wu AI Regulatory Solutions Lead Pure Global 111 Town Square Place, Suite 1203 Jersey City, NJ 07310 Re: K251607 Trade/Device Name: Oxygen Concentrator (J5A) Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: Class II Product Code: CAW Dated: October 30, 2025 Received: May 27, 2025 Dear Jarvis Wu: 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: 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, FDA may publish further announcements concerning your device in the Federal Register. 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" U.S. Food &amp; Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K251607 - Jarvis Wu Page 2 (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. {2} K251607 - Jarvis Wu Page 3 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, Bradley Q. Quinn -S Bradley Quinn Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} Oxygen Concentrator Page 9 of 45 | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K251607 | ? | | Please provide the device trade name(s). | | ? | | Oxygen Concentrator (J5A) | | | | Please provide your Indications for Use below. | | ? | | The Oxygen Concentrator provides supplemental low flow oxygen therapy for adult in the home, nursing homes, patient care facilities, etc. It is available by prescription only under the supervision of a physician, and it's not intended to support or sustain life. | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | {4} 510(k) Summary K251607 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92. 1. Submitter's Information Company Name: Foshan KYCARE Medical Equipment Co., Ltd. Establishment Registration Number: 3033859527 Address: Room 401, Building 29, Liandong Yougu Park, No. 3, Dongsan District, Jiansha Road, Danzao Town, Nanhai District, Foshan Guangdong, China Contact Person (including title): Leona Zhou (Regulatory Affair Manager) Tel: 086 18666388285 Post code: 528000 E-mail: zhouliming@kycaremedical.com Application Correspondent: Contact Person (including title): Jarvis Wu (AI Regulatory Solutions Lead) Pure Global Jersey City, NJ 07310, USA Tel: 086 19901676637 Email: jarvis.wu@pureglobal.com 2. Subject Device Information: Type of 510(k): Traditional Common Name: Portable Oxygen Concentrator Classification Name: Generator, Oxygen, Portable Trade Name: Oxygen Concentrator Model Name: J5A Review Panel: Anesthesiology Product Code: CAW Regulation Number: 868.5440 Regulatory Class: II 3. Predicate Device Information Sponsor: FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD. Trade Name: Oxygen concentrator Model: ZY-10AB/115 Common Name: Portable Oxygen Concentrator Classification Name: Generator, Oxygen, Portable 510(K) Number: K240840 Review Panel: Anesthesiology Product Code: CAW Regulation Number: 868.5440 Regulation Class: II 4. Device Description The Oxygen Concentrator is a portable concentrator which could utilize a molecular sieve and pressure swing adsorption to produce oxygen. The device can separate nitrogen by absorbing through the molecular sieve when the room air enters the device and allows the enriched oxygen to be collected. The device could provide approximately 90~96% of oxygen to patients on a continuous flow basis at a rate of 1L/min to 5L/min. The nasal cannula is not sold with the device, users need to purchase accessories by themselves that are legally marketed. The products have not undergone biocompatibility assessment of condensate precipitates according to ISO18562-4. 1 / 4 {5} The maximum altitude the subject device can operate without degradation of concentration is 2000m. 5. Intended Use / Indications for Use The Oxygen Concentrator provides supplemental low flow oxygen therapy for adult in the home, nursing homes, patient care facilities, etc. It is available by prescription only under the supervision of a physician, and it's not intended to support or sustain life. 6. Intended patient population - Population: adult - Age: above 18 years old - Health status: adult patients requiring supplemental oxygen. 7. Comparison to predicate devices | Elements of Comparison | Predicate Device(K240840) | Subject Device | Verdict | | --- | --- | --- | --- | | Company | FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD. | Foshan KYCARE Medical Equipment Co., Ltd. | -- | | Trade Name | Oxygen Concentrator | Oxygen Concentrator | -- | | Model | ZY-10AB/115 | J5A | -- | | Classification Name | Generator, Oxygen, Portable | Generator, Oxygen, Portable | Same | | 510(k) Number | K240840 | Pending | -- | | Product Code | CAW | CAW | Same | | Intended Use / Indications for Use | The Oxygen Concentrator provide supplemental oxygen to patients who require supplemental O2, by separating nitrogen from room air, by way of a molecular sieve, it can be used in the home or health care facility. It is not intended to sustain or support life. | The Oxygen Concentrator provides supplemental low flow oxygen therapy for adult in the home, nursing homes, patient care facilities, etc. It is available by prescription only under the supervision of a physician, and it's not intended to support or sustain life. | Same | | Work principle | Pressure swing adsorption principle, filtering by molecular sieve | Pressure swing adsorption principle, filtering by molecular sieve | Same | | Working mode | Continuous | Continuous | Same | | Environments of Use | Home or health care facility | Home or health care facility | Same | | Intended patient population | • Population: adult • Age: above 18 years old • Health status: adult patients requiring supplemental oxygen. | • Population: adult • Age: above 18 years old • Health status: adult patients requiring supplemental oxygen. | Same | | Performance Comparison | | | | | Power supply | AC 115V, 60Hz | AC 115V, 60Hz | Same | | Max.Input power | 550VA | 365VA | Different Note 3 | {6} Comparison in Detail(s): Note 1: | Oxygen concentration | 93% ± 3% | 93% ± 3% | Same | | --- | --- | --- | --- | | Elements of Comparison | Predicate Device(K240840) | Subject Device | Verdict | | Oxygen flow | 1-10L/min | 1-5L/min | Similar Note 1 | | Outlet pressure | 40kPa-80kPa | 40kPa-80kPa | Same | | Noise | ≤60dB (A) under max. flowrate | ≤60dB (A) under max. flowrate | Same | | Electrical classification | Class II Type BF | Class II Type BF | Same | | Alarm | Low Oxygen purity; Low & high pressure; Power loss alarm; Oxygen Sensor failure; Flow rate less than 0.4L/Min; Display Circuit Board failure | Low Oxygen purity; Low & high pressure; Power loss alarm; Oxygen Sensor failure; Flow rate less than 0.4L/Min; Display Circuit Board failure | Same | | Oxygen concentration warning | <82%, indicator yellow light and medium Blinking (0.4Hz-0.8Hz), auditory signal: Di-Di-Di 16±1 seconds interval and display error code “E2”; <73%±3%, indicator red light and fast Blinking (0.4Hz-0.8Hz), auditory signal: Di-Di-Di --- Di-Di 4±1 seconds interval and display error code “E1” | <82%, indicator yellow light and medium Blinking (0.4Hz-0.8Hz), auditory signal: Di-Di-Di 16±1 seconds interval and display error code “OXYGEN LOW”; <73%±3%, indicator red light and fast Blinking (0.4Hz-0.8Hz), auditory signal: Di-Di-Di---Di-Di 4±1 seconds interval and display error code “OXYGEN TOO LOW” | Similar Note 1 | | Operating system | Time cycle/ Pressure swing adsorption | Time cycle/ Pressure swing adsorption | Same | | Software/Hardware | Analog and digital electronics with microprocessor | Analog and digital electronics with microprocessor | Same | | LCD display | Running time; Accumulating timing | Running time; Accumulating timing | Same | | Accessories | manual | manual | Same | | Dimensions | 620 x 370 x 345mm | 380 x 250 x 590mm | Different Note 2 | | Safety Comparison | | | | | Sieve Bed | Synthetic Zeolite | Synthetic Zeolite | Same | | Biocompatibility of materials contacting user | ISO 18562-2:2017, ISO 18562-3:2017 | ISO 18562-2:2017, ISO 18562-3:2017 | Same | | EMC | Comply with IEC 60601-1-2:2014+A1:2020 | Comply with IEC 60601-1-2:2014+A1:2020 | Same | | Electric safety | Comply with IEC 60601-1-11:2015/AMD1:2020, ISO 80601-2-69:2020, IEC 60601-1-8:2020 IEC 60601-1:2005/AMD2:2020 | Comply with IEC 60601-1-11:2015/AMD1:2020, ISO 80601-2-69:2020, IEC 60601-1-6:2020 IEC 60601-1:2005/AMD2:2020 | Same | 3 / 4 {7} The "Oxygen flow" and "Oxygen concentration warning" of subject device are similar with predicate device, all of them meet the requirement of safety and performance ISO 80601-2-69. The differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device. **Note 2:** The Dimensions of subject device is slighter smaller than predicate device, the differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device. **Note 3:** The Max.Input power of subject device is smaller than predicate device due to 1-5L/min using less power composition, the differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device. ## 7. Test Summary ### 7.1 Non-Clinical Tests Performed #### 1) Electrical safety, and electromagnetic compatibility Test Electrical safety and EMC testing were conducted on the proposed device. The device was shown to comply with IEC 60601-1-2:2020 and IEC TR 60601-4-2:2016 for electromagnetic compatibility, IEC 60601-1:2020, IEC 60601-1-8:2020, IEC 60601-1-11:2020 and ISO 80601-2-69:2020 for electrical safety. #### 2) Biocompatibility Test Biocompatibility testing was performed on the subject device components in accordance with FDA guidance document entitled "Use of international Standard ISO 18562-1, "Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications- Part 1: Evaluation and Testing within a Risk Management Process." The device was shown to comply with ISO 18562-2 and ISO 18562-3. #### 3) Software verification and validation Software verification and validation testing were conducted, and documentation was provided as recommended by FDA'S Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level concern, since a malfunction of, or a latent design flaw in, the Software Device leads to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury. #### 4) Usability validation Usability evaluation was conducted and documented according to the recognized consensus standards of IEC 62366-1 and IEC 60601-1-6. The result of the usability demonstrates that all the users in testing did not show any critical errors and represented the performance of using can be smoother by extra practices without specific usability problems. The device has been found to be reasonably safe and effective for the intended users, uses and uses environments. #### 5) Cybersecurity The subject device no external interfaces, according to FDA guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", no need cybersecurity evaluation. ### 7.2 Summary of Clinical Performance Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively. ## 8. Date of the summary prepared: October 26, 2025 ### 9. Final Conclusion The subject device is as safe, as effective, and performs as well as or better than the legally marketed predicated device K240840.