Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IQJ — 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) |
|---|---|---|---|---|---|
| K823809 | CLAVICAL STRAP | Danek Medical, Inc. | 1983-01-14 | 28 | 0 |
| K823661 | CLAVICLE SUPPORT | Warm & Form, Orthopedic Materials | 1982-12-30 | 24 | 0 |
| K823157 | CLAVICLE SUPPORT | Warm & Form, Orthopedic Materials | 1982-11-10 | 16 | 0 |
| K760577 | RICHARDS CLAVICLE STRAP | Richard'S Medical Equip., Inc. | 1976-10-06 | 33 | 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