Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Creagh Medical, Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
58 daysmedian FDA review time
107 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230191 | Arise™ UHP Dilatation Catheter | Creagh Medical, Ltd. | 2023-03-22 | 57 | 0 |
| K200700 | Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Tra | Creagh Medical, Ltd. | 2020-05-14 | 58 | 0 |
| K180007 | 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter | Creagh Medical, Ltd. | 2018-04-19 | 107 | 0 |
| K113468 | ELM PTA BALLON DILATATION CATHETER | Creagh Medical, Ltd. | 2011-12-20 | 28 | 0 |
| K102645 | WILLOW/ELM PTA BALLOON DILATATION CATHETER | Creagh Medical, Ltd. | 2010-12-10 | 88 | 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