# C.R. Bard, Inc.

- Location (FDA's records): Covington, GA
- FDA decisions: 651 (1976–2026): 646 510(k) clearances and 5 original PMA approvals
- Product codes: LJS (34), FTL (25), FRN (22), LJT (22), FGE (16), DYB (16), DQO (16), KNT (15), DQY (14), LIT (13), DTK (13), DRF (11)
- 510(k) review time since 2016: median 115 days, against 110 for FDA's reviews in the same codes and years (24 of 51 faster)
- Predicates its devices cite: 439 (244 its own); citations of its devices by later devices: 592 (244 its own)
- Recalls linked to its devices: 396 (8 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bard Access Systems, Inc.: 23 (https://510kreport.com/company/bard-access-systems)
- Bard Peripheral Vascular, Inc.: 13 (https://510kreport.com/company/bard-peripheral-vascular)
- Davol Inc., Sub. C. R. Bard, Inc.: 6 (https://510kreport.com/company/davol-sub-c-r-bard)
- Genzyme Corp.: 6 (https://510kreport.com/company/genzyme)
- Tepha, Inc.: 5 (https://510kreport.com/company/tepha)
- Flowcardia, Inc.: 5 (https://510kreport.com/company/flowcardia)
- Davol, Inc.: 5 (https://510kreport.com/company/davol)
- W. L. Gore & Associates, Inc.: 5 (https://510kreport.com/company/w-l-gore-associates)

## Firms that cite its devices most
- Bard Peripheral Vascular, Inc.: 20 (https://510kreport.com/company/bard-peripheral-vascular)
- Bard Access Systems, Inc.: 15 (https://510kreport.com/company/bard-access-systems)
- Medcomp: 10 (https://510kreport.com/company/medcomp)
- Care Fusion: 6 (https://510kreport.com/company/care-fusion)
- Alliance Medical Corp.: 6 (https://510kreport.com/company/alliance-medical)
- Rita Medical Systems: 5 (https://510kreport.com/company/rita-medical-systems)
- C. R. Bard: 5 (https://510kreport.com/company/c-r-bard)
- ETHICON, Inc.: 4 (https://510kreport.com/company/ethicon)

## Its most-cited devices
- K060812: Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple (2006), cited by 19
- K922916: Bard Marlex Mesh Dart (1992), cited by 11
- K033389: Powerpicc Catheters, Models 3175155, 3175135 (2004), cited by 11
- K051991: Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line (2005), cited by 10
- K063377: Powerport Polymetric Port with 8 FR S/L Chronoflex Catheter (2007), cited by 8
- K081777: Ventrio Hernia Patch (2008), cited by 7

## Recent decisions
- K253514: Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300) (Jul 10, 2026)
- K254076: BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit (May 29, 2026)
- K252971: Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories) (Mar 17, 2026)
- K251864: Rubber Utility Catheter (Feb 23, 2026)
- K251186: Bard® Temporary Pacing Electrode Catheter  Needle / Cannula (Introducer) (May 15, 2025)
- K241334: Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH™ Temporary Pacing Electrode Catheter, (Jan 31, 2025)
- K230356: Aspirex™ Thrombectomy System (Mar 31, 2023)
- K223177: Highlander™ 014 PTA Balloon Dilatation Catheter (Jan 20, 2023)

Source page: https://510kreport.com/company/cr-bard