Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
JYM · 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) |
|---|---|---|---|---|---|
| K924901 | DEANS DISPOSABLE T-TUBE INSERTER | Exmoor Plastics , Ltd. | 1993-01-28 | 141 | 0 |
| K870978 | T-TUBE INSERTER | Sur-Med Instruments, Inc. | 1987-03-19 | 9 | 0 |
| K822349 | ARMSTRONG V TUBE SUCTION INSERTER | Treace Medical, Inc. | 1982-09-13 | 38 | 0 |
| K822348 | TYTAN TUBE INSERTER | Treace Medical, Inc. | 1982-09-07 | 32 | 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