510(k) Report

FDA applicant

C. R. Bard

Warwick, RI9 decisions2012–20200 recalls

FDA records 9 decisions for C. R. Bard (Warwick, RI) from 2012 to 2020: 9 510(k) clearances. Most are in product codes PIJ (Collagen Surgical Mesh Containing Drugs) and MSD (Catheter, Hemodialysis, Implanted). Since 2016 its 510(k)s took a median of 76 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 13 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 and plastic surgery panel, where it files most

How often FDA has decided C. R. Bard’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2012: 12014: 12015: 22016: 12017: 22018: 12020: 1
2012high 2 (2015) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — C. R. Bard by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • PIJCollagen Surgical Mesh Containing Drugs2decisions
  • MSDCatheter, Hemodialysis, Implanted1decision
  • PNOCatheter, Percutaneous, Cutting/Scoring1decision
  • FTLMesh, Surgical, Polymeric1decision
  • OODSurgical Film1decision
  • LKBPad, Alcohol, Device Disinfectant1decision

Also: FTM (1), IYO (1).

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 76 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 90 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 13 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 times; 1 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.

  • K190527GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term…C. R. Bard · 20203cite it
  • K112791Sitescrub Ipa DeviceC. R. Bard · 20122cite it
  • K182281Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle TechC. R. Bard · 20182cite it
  • K172571ULTRASCORE Focused Force PTA BalloonC. R. Bard · 20171cites it
  • K151177XenMatrix AB Surgical GraftC. R. Bard · 20151cites it
  • K170294VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle, VENTRALIGHT ST Mesh with ECHO 2…C. R. Bard · 20171cites it

What has FDA decided for it lately?

  • K190527GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term…C. R. Bard · 2020
  • K182281Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle TechC. R. Bard · 2018
  • K172571ULTRASCORE Focused Force PTA BalloonC. R. Bard · 2017
  • K170294VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle, VENTRALIGHT ST Mesh with ECHO 2…C. R. Bard · 2017
  • K162193XenMatrix AB Surgical GraftC. R. Bard · 2016
  • K151177XenMatrix AB Surgical GraftC. R. Bard · 2015
  • K142818Phasix MeshC. R. Bard · 2015
  • K140501Xenmatrix Surgical GraftC. R. Bard · 2014

All 9 as C. R. Bard →