Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Flocare Medical · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
78 daysmedian FDA review time
84 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K912700 | FLOCARE DRY CAS SAMPLING PORT MODELS | Flocare Medical | 1991-09-11 | 84 | 0 |
| K912699 | FLOCARE LF-A | Flocare Medical | 1991-09-11 | 84 | 0 |
| K904193 | FLOCARE | Flocare Medical | 1990-11-29 | 78 | 0 |
| K903404 | FLOCARE F | Flocare Medical | 1990-09-25 | 56 | 0 |
| K902501 | FLOCARE N | Flocare Medical | 1990-07-02 | 27 | 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