510(k) Report

FDA applicant

Bard Access Systems, Inc. (Bard Has Joined Bd)

Salt Lake Ciy,, UT2 decisions2019–20200 recalls

FDA records 2 decisions for Bard Access Systems, Inc. (Bard Has Joined Bd) (Salt Lake Ciy,, UT) from 2019 to 2020: 2 510(k) clearances. All are in product code FOZ (Catheter, Intravascular, Therapeutic…). Its devices cite 2 predicates, 1 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, general hospital panel, where it files most

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

FDA decisions per year

1in 2020

2019: 12020: 1
2019high 1 (2019) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Bard Access Systems, Inc. (Bard Has Joined Bd) by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bard Access Systems, Inc. (Bard Has…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Bard”

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