Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
ENZ · 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) |
|---|---|---|---|---|---|
| K944032 | VIDEO SCOPE SYSTEM (LARYNGOSCOPE) | Jedmed Instrument Co. | 1995-09-15 | 394 | 0 |
| K943904 | RIGID TELESCOPES | Karl Storz Endoskop GmbH | 1994-10-14 | 64 | 0 |
| K790845 | DUALUME LARYNGEAL EXAMINATION TELESCOPE | National Medical Technology | 1979-07-24 | 81 | 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