Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Flexicath , Ltd. — 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) |
|---|---|---|---|---|---|
| K111939 | M/29TM - PRESSURE INJECTABLE | Flexicath , Ltd. | 2012-07-11 | 369 | 0 |
| K092629 | SNM FIRMGRIP | Flexicath , Ltd. | 2009-09-25 | 29 | 0 |
| K080793 | FIRMGRIP | Flexicath , Ltd. | 2008-10-16 | 210 | 0 |
| K063363 | FIRMGRIP PERIPHERALLY INSERTED CATHETER DEVICE | Flexicath , Ltd. | 2007-05-07 | 181 | 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