Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HWN · 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) |
|---|---|---|---|---|---|
| K854241 | AOT EXTERNAL COMPRESS DEVICE | Advanced Ortho-Technology, Inc. | 1986-03-03 | 133 | 0 |
| K792253 | ARICULATED TENSION DEVICE SYNTHES TEN | Synthes (Usa) | 1979-12-05 | 28 | 0 |
| K770349 | RIGID TEACHING ATTACHMENT | Richard Wolf Medical Instruments Corp. | 1977-03-07 | 13 | 0 |
| K760970 | FLORIO CPC BAND | Richard'S Medical Equip., Inc. | 1976-11-23 | 19 | 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