510(k) Report

FDA applicant

Bard Access Systems, Inc. (C.R. Bard, Inc.)

Salt Lake Ciy,, UT3 decisions2021–20240 recalls

FDA records 3 decisions for Bard Access Systems, Inc. (C.R. Bard, Inc.) (Salt Lake Ciy,, UT) from 2021 to 2024: 3 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and FOZ (Catheter, Intravascular, Therapeutic…). Since 2016 its 510(k)s took a median of 131 days from receipt to decision, against 177 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Bard Access Systems, Inc. (C.R. Bard, Inc.)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2021: 12023: 12024: 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Bard Access Systems, Inc. (C.R. Bard, Inc.) by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic2decisions
  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 131 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 177 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K211193BD Prevue II Peripheral Vascular Vascular Access SystemBard Access Systems, Inc. (C.R. Bard, Inc.) · 20212cite it

What has FDA decided for it lately?

  • K233106AccuCath Ace™ Intravascular CatheterBard Access Systems, Inc. (C.R. Bard, Inc.) · 2024
  • K231283SiteRite™ 9 Ultrasound SystemBard Access Systems, Inc. (C.R. Bard, Inc.) · 2023
  • K211193BD Prevue II Peripheral Vascular Vascular Access SystemBard Access Systems, Inc. (C.R. Bard, Inc.) · 2021

All 3 as Bard Access Systems, Inc. (C.R. Bard, Inc.) →

Other applicant names beginning “Bard”

FDA records each applicant name separately; these may or may not be the same firm.

Bard Peripheral Vascular, Inc. 46Bard Access Systems, Inc. 22Bard Cardiosurgery Div 3Bard Diagnostic Sciences,Inc. 3Bard Medical Div. 3Bard Electrophysiology 3Bard Interventional Products Div. 2Bard Access Systems, Inc. (Bard Has Joined Bd) 2Bard Peripheral Vacular, Inc. 1Bard Reproductive Systems 1Bard Gynecology and Radiology 1Bard Electro Medical Systems, Inc. 1