Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OJP — 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) |
|---|---|---|---|---|---|
| K150741 | TSolution One w/ACG surgical System | THINK Surgical, Inc. | 2015-10-22 | 213 | 0 |
| K140585 | CTC TCAT(R)-TPLAN(R) SURGICAL SYSTEM | Curexo Technology Corporation | 2014-08-18 | 164 | 0 |
| K140038 | DIGIMATCH ORTHODOC ROBODOC ENCORE SURGICAL SYSTEM | Curexo Technology Corporation | 2014-05-27 | 140 | 0 |
| K072629 | DIGIMATCH ROBODOC SURGICAL SYSTEM | Integrated Surgical Systems, Inc. | 2008-08-06 | 324 | 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