Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Flexible Stenting Solutions, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
84 daysmedian FDA review time
428 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K121125 | FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM | Flexible Stenting Solutions, Inc. | 2012-07-06 | 84 | 0 |
| K120452 | FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM | Flexible Stenting Solutions, Inc. | 2012-04-24 | 70 | 0 |
| K112522 | FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM | Flexible Stenting Solutions, Inc. | 2011-12-30 | 121 | 1 |
| K102519 | FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM MODEL FLX-DDLL | Flexible Stenting Solutions, Inc. | 2010-11-22 | 81 | 0 |
| K081996 | FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM | Flexible Stenting Solutions, Inc. | 2009-09-15 | 428 | 1 |
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