Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pedicraft, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
154 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K925817 | HEAD & FOOT END DROP PEDI-CRIB | Pedicraft, Inc. | 1993-04-20 | 154 | 0 |
| K925949 | PEDICRAGT BASSINET | Pedicraft, Inc. | 1993-04-20 | 147 | 0 |
| K905630 | INFANT REFLUX SLING | Pedicraft, Inc. | 1991-03-13 | 89 | 0 |
| K905629 | PEDICRAFT INFANT REFLUX WEDGE | Pedicraft, Inc. | 1991-03-13 | 89 | 0 |
| K821773 | PEDICRAFT BED, MODEL B2944 | Pedicraft, Inc. | 1982-06-23 | 7 | 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