Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Collins Medical, Inc. — 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) |
|---|---|---|---|---|---|
| K030917 | GEM; HAWK; EAGLE; MODELS 004110, 0044120, 004130 | Collins Medical, Inc. | 2003-05-14 | 51 | 0 |
| K030464 | GEM, MODEL 004110 | Collins Medical, Inc. | 2003-03-14 | 30 | 0 |
| K011344 | INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAP | Collins Medical, Inc. | 2002-05-17 | 380 | 0 |
| K992743 | COLLINS CPL | Collins Medical, Inc. | 1999-09-13 | 28 | 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