510(k) Report

FDA applicant

C.R. Bard, Inc.

Covington, GA651 decisions1976–2026396 recalls

FDA records 651 decisions for C.R. Bard, Inc. (Covington, GA) from 1976 to 2026: 646 510(k) clearances and 5 original PMA approvals. Most are in product codes LJS (Catheter, Intravascular, Therapeutic…) and FTL (Mesh, Surgical, Polymeric). Since 2016 its 510(k)s took a median of 115 days from receipt to decision, against 110 for FDA’s reviews in the same codes and years. Its devices cite 439 predicates, 244 of them its own earlier devices. 396 recalls are linked to its devices, 8 Class I.

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

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

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

FDA decisions per year

2in 2025

2007: 182008: 152009: 172010: 132011: 152012: 112013: 112014: 132015: 172016: 192017: 132018: 72019: 72020: 42021: 62022: 42023: 22025: 22026 (partial year): 4
2007high 19 (2016) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

16in 2026

2007: 152008: 792009: 92010: 62011: 102012: 62013: 72014: 212015: 92016: 13, 5 Class I2017: 42018: 182019: 402020: 272021: 412022: 12023: 392024: 12025: 10, 1 Class I2026 (partial year): 16, 2 Class I
2007high 79 (2008) · low 1 (2022)2026

Class I Class II/III not classified

FIG. 1 — C.R. Bard, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like C.R. Bard, Inc.’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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Which product codes does it file in?

  • LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days34decisions
  • FTLMesh, Surgical, Polymeric25decisions
  • FRNPump, Infusion22decisions
  • LJTPort & Catheter, Implanted, Subcutaneous, Intravascular22decisions
  • FGEStents, Drains And Dilators For The Biliary Ducts16decisions
  • DYBIntroducer, Catheter16decisions

Also: DQO (16), KNT (15), DQY (14), LIT (13), DTK (13), DRF (11).

How long do its 510(k) reviews take?

Since 2016, its 51 510(k)s took a median of 115 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 110 days; 24 of its 51 were faster than that.

Whose devices does it build on?

Its devices cite 439 predicates; 244 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 592 times; 244 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.

  • K060812Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-MultipleC.R. Bard, Inc. · 200619cite it
  • K922916Bard Marlex Mesh DartC.R. Bard, Inc. · 199211cite it
  • K033389Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 200411cite it
  • K051991Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power LineC.R. Bard, Inc. · 200510cite it
  • K063377Powerport Polymetric Port with 8 FR S/L Chronoflex CatheterC.R. Bard, Inc. · 20078cite it
  • K081777Ventrio Hernia PatchC.R. Bard, Inc. · 20087cite it

What has FDA decided for it lately?

  • K253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric…C.R. Bard, Inc. · 2026
  • K254076BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter KitC.R. Bard, Inc. · 2026
  • K252971Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)C.R. Bard, Inc. · 2026
  • K251864Rubber Utility CatheterC.R. Bard, Inc. · 2026
  • K251186Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)C.R. Bard, Inc. · 2025
  • K241334Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr.…C.R. Bard, Inc. · 2025
  • K230356Aspirex™ Thrombectomy SystemC.R. Bard, Inc. · 2023
  • K223177Highlander™ 014 PTA Balloon Dilatation CatheterC.R. Bard, Inc. · 2023

All 651 as C.R. Bard, Inc. →

What has been recalled?

396 recalls linked to its devices; the latest:

  • K133456Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605150; Power-Trialysis…Aug 10, 2026Class I
  • K030268DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625150; DuoGlide Short-Term…Aug 10, 2026Class I
  • K040658Products that contain the Pericare Wipes: *Bardex I.C. Complete Care Foley Catheter Tray…Jun 25, 2026Class II
  • K910197Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter Tray REF…Jun 25, 2026Class II
  • K040504Products that contain the Pericare Wipes: Bard Foley Tray With Lubri-Sil All-Silicone…Jun 25, 2026Class II
  • K213203CK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188770…May 21, 2026Class II