Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
MOJ · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230161 | ONLINE TDM Phenytoin - Free Phenytoin application | Roche Diagnostics | 2023-03-30 | 69 | 0 |
| K952555 | COBAS-FP APPLICATION FOR FREE PHENYTOIN, COBAS-FP PHENYTOIN | Roche Diagnostic Systems, Inc. | 1995-07-31 | 59 | 0 |
| K950280 | TDX(R)/TDXFLX(R) FREE PHENYTOIN II | Abbott Laboratories | 1995-05-02 | 98 | 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