Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
UC-CARE , Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
191 daysmedian FDA review time
592 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260161 | SmartGuide Disposable Guides and Grids | UC-CARE , Ltd. | 2026-07-30 | 191 | 0 |
| K250664 | Navigo Workstation 2.3 (FPRMC00039) | UC-CARE , Ltd. | 2025-08-07 | 155 | 0 |
| K173054 | Navigo Workstation Version 2.0 | UC-CARE , Ltd. | 2018-01-16 | 110 | 0 |
| K160934 | UC-CARE NaviGo Workstation | UC-CARE , Ltd. | 2017-02-06 | 308 | 0 |
| K100784 | UC-CARE NAVIGO SYTEM | UC-CARE , Ltd. | 2011-11-01 | 592 | 0 |
| K090978 | UC-CARE WARMING SYSTEM | UC-CARE , Ltd. | 2009-08-10 | 126 | 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