Data / Medical devices / China / Foshan Kycare Medical Equipment Co. Ltd
Foshan Kycare Medical Equipment Co. Ltd: FDA-registered device maker in Foshan City Guangdong, China, 2 510(k) clearances
Foshan Kycare Medical Equipment Co. Ltd is registered with the FDA (registration 3033859527) in Foshan City Guangdong, China. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 29, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3033859527
- Address
- Room 401, Building 29, Liandong Yougu Park, No. 3 Dongsan District, Jiansha Road, Danzao Town, Nanhai District, Foshan City Guangdong, China, 528000
- Owner or operator
- Foshan KYCARE Medical Equipment Co. Ltd (10091799)
- Roles
- Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- November 2, 2024
- Registered through
- 2026
- Brand names listed
- Firestop Cannula Valve, Flowmeter, KYCARE J10A OXYGEN CONCENTRATOR, Oxygen Concentrator (J5A), Oxygen Concentrator (Model: J10A), ZY5BA Oxygen Concentrator
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Flowmeter, Calibration, Gas | BXY | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Flowmeter, Tube, Thorpe, Back-Pressure Compensated | CAX | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Generator, Oxygen, Portable | CAW | 2 | Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 29, 2025 | K251534 | Oxygen Concentrator (J10A) | CAW | Substantially Equivalent | Foshan Kycare Medical Equipment Co., Ltd. | accessdata.fda.gov |
| November 21, 2025 | K251607 | Oxygen Concentrator (J5A) | CAW | Substantially Equivalent | Foshan Kycare Medical Equipment Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Generator, Oxygen, Portable
- All makers of Flowmeter, Tube, Thorpe, Back-Pressure Compensated
- All makers of Flowmeter, Calibration, Gas
Updated December 29, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.