Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shenzhen Finicare Co., Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
137 daysmedian FDA review time
240 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252769 | Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP | Shenzhen Finicare Co., Ltd. | 2025-10-02 | 30 | 0 |
| K243136 | Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR2 | Shenzhen Finicare Co., Ltd. | 2025-02-14 | 137 | 0 |
| K242721 | Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP | Shenzhen Finicare Co., Ltd. | 2024-10-04 | 24 | 0 |
| K231367 | Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-B | Shenzhen Finicare Co., Ltd. | 2023-09-18 | 130 | 0 |
| K220113 | Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,F | Shenzhen Finicare Co., Ltd. | 2022-05-31 | 137 | 0 |
| K181215 | Infrared Thermometer | Shenzhen Finicare Co., Ltd. | 2019-01-02 | 240 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda