FDA applicant
Becton Dickinson Infusion Therapy Systems, Inc.
FDA records 36 decisions for Becton Dickinson Infusion Therapy Systems, Inc. (Sandy, UT) from 1997 to 2026: 36 510(k) clearances. Most are in product codes FOZ (Catheter, Intravascular, Therapeutic…) and JKA (Tubes, Vials, Systems, Serum Separators, Blood…). Since 2016 its 510(k)s took a median of 97 days from receipt to decision, against 122 for FDA’s reviews in the same codes and years. Its devices cite 26 predicates, 17 of them its own earlier devices. 36 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Becton Dickinson Infusion Therapy Systems, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
6in 2025
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Becton Dickinson Infusion Therapy…’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 “Becton”
FDA records each applicant name separately; these may or may not be the same firm.