Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
FOC · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K950176 | PREMIE U-BAG URINE SPECIMEN COLLECTOR | Hollister, Inc. | 1995-02-07 | 21 | 0 |
| K943752 | RIMECO MIDSTREAM URINE COLLECTOR | Rimeco Products, Inc. | 1994-11-01 | 91 | 0 |
| K911329 | BARD(R) SURECATCH PEDIATRIC URINE COLLECT DEVICE | C.R. Bard, Inc. | 1991-05-28 | 63 | 0 |
| K771368 | PORTABLE INFANT VENTILATOR | Cavitron Corp. | 1977-08-04 | 10 | 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