FDA applicant
Bard Access Systems, Inc.
FDA records 22 decisions for Bard Access Systems, Inc. (Salt Lake City, UT) from 1993 to 2025: 22 510(k) clearances. Most are in product codes LJT (Port & Catheter, Implanted, Subcutaneous…) and LJS (Catheter, Intravascular, Therapeutic…). Since 2016 its 510(k)s took a median of 30 days from receipt to decision, against 220 for FDA’s reviews in the same codes and years. Its devices cite 37 predicates, 4 of them its own earlier devices. 7 recalls are linked to its devices, 1 Class I.
FDA’s records also spell it “Bard Access Systems”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Bard Access Systems, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Bard Access Systems, Inc.’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 “Bard”
FDA records each applicant name separately; these may or may not be the same firm.