Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Instent, 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) |
|---|---|---|---|---|---|
| K955041 | INSTENT ESOPHACOIL SELF-EXPANDING STENT SYSTEM | Instent, Inc. | 1996-02-21 | 110 | 0 |
| K945498 | INSTENT ENDOCOIL-T(TM) TRANSHEPATIC BILIARY ENDOPROSTHESIS | Instent, Inc. | 1995-09-12 | 308 | 0 |
| K924387 | INSTENT ENDOCOIL BILIARY ENDOPROSTHESIS | Instent, Inc. | 1995-09-08 | 1103 | 0 |
| K941487 | INSTENT ESOPHACOIL ESOPHAGEAL PROSTHESIS | Instent, Inc. | 1995-02-23 | 332 | 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