Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
106 daysmedian FDA review time
269 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K180395 | EZ-IO Intraosseous Vascular Access System | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2018-11-09 | 269 | 0 |
| K163513 | Arrow Endurance Extended Dwell Peripheral Catheter System | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2017-02-24 | 71 | 1 |
| K161313 | ARROW Pressure Injectable Midline Catheter with Chlorag+ard | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2016-08-24 | 106 | 1 |
| K160018 | Arrow Quickflash Arterial Catheterization Device | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2016-06-13 | 160 | 2 |
| K153487 | CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VP | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2016-02-04 | 62 | 1 |
| K153423 | CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2016-01-28 | 64 | 1 |
| K152272 | Arrow Endurance Extended Dwell Peripheral Catheter System | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2015-11-23 | 103 | 0 |
| K143102 | Multi-Lumen Acute Hemodialysis Catheter for High Volume Infu | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2015-07-24 | 268 | 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