510(k) Report

FDA applicant

Bard Access Systems, Inc (Bas)[Wholly-Owned Subsidiary of Bd]

Salt Lake Ciy,, UT1 decision2021–20212 recalls

FDA records 1 decision for Bard Access Systems, Inc (Bas)[Wholly-Owned Subsidiary of Bd] (Salt Lake Ciy,, UT) in 2021: 1 510(k) clearance. All are in product code MHC (Needle, Interosseous). Its devices cite 1 predicate, 0 of them its own earlier devices. 2 recalls are linked to its devices, 2 Class I.

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

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Bard Access Systems, Inc (Bas)[Wholly-Owned Subsidiary of Bd]’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

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

2026 so far, outlined.

Recalls per year

1in 2026

2022: 1, 1 Class I2026 (partial year): 1, 1 Class I
2021high 1 (2022) · low 0 (2021)2026

Class I Class II/III not classified

FIG. 1 — Bard Access Systems, Inc (Bas)[Wholly-Owned Subsidiary of… 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?

  • MHCNeedle, Interosseous1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K203193BD Intraosseous Infusion SystemBard Access Systems, Inc (Bas)[Wholly-Owned Subsidiary of Bd] · 20211cites it

What has FDA decided for it lately?

  • K203193BD Intraosseous Infusion SystemBard Access Systems, Inc (Bas)[Wholly-Owned Subsidiary of Bd] · 20212 Class I recalls

The one decision as Bard Access Systems, Inc (Bas)[Wholly-Owned Subsidiary of Bd] →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K191976BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit for Powered…Jul 30, 2026Class I
  • K203193Intraosseous needle and driver. Catalog/Device Name: D015151NK/BD Needle Kit for Powered…Jun 20, 2022Class I

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 Access Systems, Inc. (C.R. Bard, Inc.) 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 1