510(k) Report

FDA applicant

C.R. Bard, Inc (Bard Has Joined Bd)

Salt Lake Ciy,, UT1 decision2018–20181 recall

FDA records 1 decision for C.R. Bard, Inc (Bard Has Joined Bd) (Salt Lake Ciy,, UT) in 2018: 1 510(k) clearance. All are in product code LJS (Catheter, Intravascular, Therapeutic…). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 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 C.R. Bard, Inc (Bard Has Joined Bd)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2018: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

1in 2026

2026 (partial year): 1
2018high 1 (2026) · low 0 (2018)2026

Class I Class II/III not classified

FIG. 1 — C.R. Bard, Inc (Bard Has Joined Bd) by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K1805483F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC…C.R. Bard, Inc (Bard Has Joined Bd) · 20181 recall

The one decision as C.R. Bard, Inc (Bard Has Joined Bd) →

What has been recalled?

1 recall linked to its devices; the latest:

  • K180548CK000525B PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236129…May 21, 2026Class II