Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Arrow International, LLC (A subsidiary of Teleflex, 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) |
|---|---|---|---|---|---|
| K243599 | Arrow™ Endurance™ Extended Dwell Peripheral Catheter System | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | 2025-03-14 | 113 | 0 |
| K242281 | Arrow Endurance Extended Dwell Peripheral Catheter System (E | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | 2024-12-20 | 140 | 0 |
| K220280 | Arrow Stiffening Stylet | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | 2022-08-30 | 210 | 0 |
| K220363 | VPS Rhythm DLX Device with TipTracker Technology | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | 2022-08-22 | 195 | 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