Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OYK — Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
112 daysmedian FDA review time
335 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243173 | Salto Talaris Ankle PSI System | 3D Systems, Inc. | 2024-10-25 | 25 | 0 |
| K243174 | Cadence Ankle PSI System | 3D Systems, Inc. | 2024-10-25 | 25 | 0 |
| K241148 | Salto Talaris Ankle PSI System | 3D Systems, Inc. | 2024-08-30 | 127 | 0 |
| K241326 | Cadence Ankle PSI System | 3D Systems, Inc. | 2024-08-30 | 112 | 0 |
| K231585 | Vantage PSI System | 3D Systems, Inc. | 2023-06-30 | 30 | 0 |
| K223326 | Axiom PSR System | Restor3D | 2023-03-30 | 150 | 0 |
| K193432 | Vantage PSI System | 3D Systems | 2020-11-09 | 335 | 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