Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Uzinmedicare Co. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
273 daysmedian FDA review time
416 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K210124 | Synergy Gold (SG) Portable (Models MM011450 and MM011460) | Uzinmedicare Co. | 2021-10-19 | 273 | 0 |
| K191109 | Spectra Q | Uzinmedicare Co. | 2020-01-22 | 271 | 0 |
| K191208 | Spectra Cashmere | Uzinmedicare Co. | 2019-10-11 | 158 | 0 |
| K181784 | Spectra S3 Plus | Uzinmedicare Co. | 2018-11-30 | 150 | 0 |
| K150476 | Spectra S1Plus and Spectra S2 Plus | Uzinmedicare Co. | 2016-04-15 | 416 | 0 |
| K093145 | SPECTRA SERIES BREAST PUMP | Uzinmedicare Co. | 2010-08-13 | 312 | 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