FDA applicant
Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
FDA records 17 decisions for Arrow International, Inc. (Subsidiary of Teleflex, Inc.) (Reading, PA) from 2012 to 2022: 17 510(k) clearances. Most are in product codes LJS (Catheter, Intravascular, Therapeutic…) and PND (Midline Catheter). Since 2016 its 510(k)s took a median of 71 days from receipt to decision, against 128 for FDA’s reviews in the same codes and years. Its devices cite 28 predicates, 9 of them its own earlier devices. 46 recalls are linked to its devices, 8 Class I.
FDA’s records also spell it “Arrow International (Subsidiary of Teleflex Inc.)”, “Arrow International, Inc. (Subsidiary of Teleflex”, “Arrow International, LLC Subsidiary of Teleflex Incorporated”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Arrow International, Inc. (Subsidiary of Teleflex, Inc.)’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
5in 2026
Class I Class II/III not classified
Planning a device like Arrow International, Inc. (Subsidiary…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Arrow”
FDA records each applicant name separately; these may or may not be the same firm.