Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medcare Flaga · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K043132 | UNIVERSAL XACTTRACE | Medcare Flaga | 2004-12-21 | 39 | 0 |
| K041724 | COMPASS M10 SYSTEM | Medcare Flaga | 2004-09-28 | 96 | 0 |
| K041904 | COMPASS F10 SYSTEM | Medcare Flaga | 2004-09-07 | 54 | 0 |
| K024322 | EMBLA N7000 | Medcare Flaga | 2003-10-27 | 305 | 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