Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Zinetics Medical, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K921682 | ZINETICS AMC | Zinetics Medical, Inc. | 1994-12-29 | 995 | 0 |
| K910694 | ZINETICS INTERNAL REFERENCE PROBE | Zinetics Medical, Inc. | 1991-05-17 | 87 | 0 |
| K884527 | ZINETICS(R) EMC | Zinetics Medical, Inc. | 1989-02-28 | 124 | 0 |
| K883319 | HILL NASOGASTRIC TUBE | Zinetics Medical, Inc. | 1988-12-05 | 122 | 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