Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
FFH · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K905016 | PEDIATRIC AND INFANT CATH KITS | Davol, Inc. | 1990-12-20 | 43 | 0 |
| K896581 | PEDIATRIC DRAIN BAG | Laytech Medical Co. | 1990-01-31 | 75 | 0 |
| K871789 | INTECARE PEDIATRIC URINE COLLECTOR | Mercury Enterprises, Inc. | 1987-08-10 | 96 | 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