Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
ISH · 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) |
|---|---|---|---|---|---|
| K051256 | SILVERSEAL ORTHOTIC COMPONENT WITH X-STATIC | Noble Fiber Technologies, Inc. | 2005-07-21 | 66 | 0 |
| K823396 | FREE FLEX HEEL HEIGHT ADJUSTOR | Orthopedic Systems, Inc. | 1982-11-29 | 17 | 0 |
| K820505 | ANKLE/FOOT EXTERNAL | Mauch Laboratories, Inc. | 1982-03-08 | 11 | 0 |
| K791331 | THE TUCKER-SACH FOOT AND TUCKER-SYME FT | Kiswood Manufacturing, Inc. | 1979-08-03 | 16 | 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