Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Arrow International (Subsidiary of Teleflex Inc.) · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
108 daysmedian FDA review time
223 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K132133 | CG+ ARROW JACC POWERED BY ARROW VPS STYLET | Arrow International (Subsidiary of Teleflex Inc.) | 2013-09-26 | 77 | 2 |
| K122854 | ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER | Arrow International (Subsidiary of Teleflex Inc.) | 2013-01-04 | 108 | 2 |
| K121501 | ARROW JUGULAR AXILLO-SUBCLAVIAN CENTRAL CATHETER (JACC) | Arrow International (Subsidiary of Teleflex Inc.) | 2012-11-29 | 192 | 0 |
| K122545 | CG+ ARROW PICC POWERED BY ARROW VPS STYLET | Arrow International (Subsidiary of Teleflex Inc.) | 2012-09-20 | 30 | 2 |
| K121941 | ARROW PICC POWERED BY ARROW VPS STYLET | Arrow International (Subsidiary of Teleflex Inc.) | 2012-09-07 | 67 | 6 |
| K112896 | ARRW EVOLUTION | Arrow International (Subsidiary of Teleflex Inc.) | 2012-05-10 | 223 | 4 |
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