Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
ESZ · 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) |
|---|---|---|---|---|---|
| K974224 | ENDOLYMPHATIC SAC TO MASTOID T-SHUNT | Exmoor Plastics , Ltd. | 1998-01-27 | 78 | 0 |
| K952227 | C-FLEX ENDOLYMPHATIC SHUNT | Trebay Medical Corp. | 1995-06-16 | 35 | 0 |
| K897049 | GIBSON ENDOLYMPHATIC SHUNT | Hood Laboratories | 1990-03-16 | 88 | 0 |
| K834094 | AUSTIN ENDOLYMPH DISPERSMENT SHUNT | Treace Medical, Inc. | 1984-09-20 | 297 | 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