Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IOZ · 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) |
|---|---|---|---|---|---|
| K830243 | ABDUCTION PILLOW | Warm & Form, Orthopedic Materials | 1983-03-08 | 42 | 0 |
| K823820 | ABDUCTION PILLOW | Danek Medical, Inc. | 1983-01-14 | 28 | 0 |
| K810557 | HIP ABDUCTION SPLINT | Orthomedics | 1981-03-13 | 11 | 0 |
| K780375 | PAVLIK HARNESS | Biomet, Inc. | 1978-03-15 | 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