Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MOQ · 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) |
|---|---|---|---|---|---|
| K081713 | VERTEBRAL ACCESS SYSTEM BY VIDACARE | Vidacare Corporation | 2008-11-21 | 157 | 0 |
| K013133 | NORDIX INC RECHARGEABLE BATTERY PART NUMBER 2116 | Nordix, Inc. | 2001-11-13 | 55 | 0 |
| K980224 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER | Alexander Mfg. Co. | 1998-04-02 | 70 | 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