Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Uzinmedicare Co., Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
256 daysmedian FDA review time
437 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260956 | Spectra Platinum Mini | Uzinmedicare Co., Ltd. | 2026-06-04 | 73 | 0 |
| K250208 | SPECTRA Wearable 2 | Uzinmedicare Co., Ltd. | 2026-04-06 | 437 | 0 |
| K251423 | Spectra S1 Pro; Spectra S2 Pro | Uzinmedicare Co., Ltd. | 2026-02-06 | 274 | 0 |
| K251932 | Spectra Platinum | Uzinmedicare Co., Ltd. | 2025-11-25 | 154 | 0 |
| K220926 | Spectra Wearable | Uzinmedicare Co., Ltd. | 2022-12-12 | 256 | 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