Data / Medical devices / China / Shenzhen Finicare Co., Ltd.
Shenzhen Finicare Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 6 510(k) clearances
Shenzhen Finicare Co., Ltd. is registered with the FDA (registration 3015136472) in Shenzhen Guangdong, China. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 2, 2025. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3015136472
- Address
- 201 and 301 of Building A22, Building A22 and A23, No.4 Industrial Park, Tantou Community, Songgang Street Bao an District, Shenzhen Guangdong, China, 518105
- Owner or operator
- Shenzhen Finicare Co., Ltd. (10059798)
- Roles
- Manufacturer
- First device listed
- February 24, 2019
- Registered through
- 2027
- Brand names listed
- Electronic Thermometer FC-TM100, Electronic Thermometer FC-TM101, Electronic Thermometer FC-TM110, Electronic Thermometer FC-TM111, Electronic Thermometer FC-TM112, Electronic Thermometer FC-TM113, Electronic Thermometer FC-TM120, Electronic Thermometer FC-TM121 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clinical Electronic Thermometer | SDV | 2 | Manufacturer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | 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 |
|---|---|---|---|---|---|---|
| October 2, 2025 | K252769 | Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116) | DXN | Substantially Equivalent | Shenzhen Finicare Co., Ltd. | accessdata.fda.gov |
| February 14, 2025 | K243136 | Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209) | FLL | Substantially Equivalent | Shenzhen Finicare Co., Ltd. | accessdata.fda.gov |
| October 4, 2024 | K242721 | Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131) | DXN | Substantially Equivalent | Shenzhen Finicare Co., Ltd. | accessdata.fda.gov |
| September 18, 2023 | K231367 | Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221) | DXN | Substantially Equivalent | Shenzhen Finicare Co., Ltd. | accessdata.fda.gov |
| May 31, 2022 | K220113 | Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112) | DXN | Substantially Equivalent | Shenzhen Finicare Co., Ltd. | accessdata.fda.gov |
| January 2, 2019 | K181215 | Infrared Thermometer | FLL | Substantially Equivalent | Shenzhen Finicare Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Clinical Electronic Thermometer
- All makers of Continuous Measurement Thermometer
Updated October 2, 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.