Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
ITM · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
36 daysmedian FDA review time
66 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K832742 | EXTENSION CONTROL KNEE ORTHOSIS | Orthomedics | 1983-09-20 | 36 | 0 |
| K812064 | POLI-AXIAL KNEE CAGE | Generation II Orthotics, Inc. | 1981-08-13 | 23 | 0 |
| K770899 | FRACTURE CAST BRACE, POLY | Chase Mfg. Co. | 1977-07-21 | 66 | 0 |
| K770900 | CAST BRWM, FRACTURE | Chase Mfg. Co. | 1977-07-21 | 66 | 0 |
| K760573 | IMPROVED KNEE DRESSING | Richard'S Medical Equip., Inc. | 1976-10-05 | 32 | 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