# C. R. Bard

- Location (FDA's records): Warwick, RI
- FDA decisions: 9 (2012–2020): 9 510(k) clearances
- Product codes: PIJ (2), MSD (1), PNO (1), FTL (1), OOD (1), LKB (1), FTM (1), IYO (1)
- 510(k) review time since 2016: median 76 days, against 90 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 13 (1 its own); citations of its devices by later devices: 11 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- C.R. Bard, Inc.: 5 (https://510kreport.com/company/cr-bard)
- Tepha, Inc.: 3 (https://510kreport.com/company/tepha)
- Bard Peripheral Vascular, Inc.: 1 (https://510kreport.com/company/bard-peripheral-vascular)
- Excelsior Medical Corp.: 1 (https://510kreport.com/company/excelsior-medical)
- Aplicare, Inc.: 1 (https://510kreport.com/company/aplicare)
- Brennen Medical, Inc.: 1 (https://510kreport.com/company/brennen-medical)

## Firms that cite its devices most
- C.R. Bard, Inc.: 4 (https://510kreport.com/company/cr-bard)
- Becton, Dickinson & CO: 2 (https://510kreport.com/company/becton-dickinson)
- Bard Access Systems, Inc. (C.R. Bard, Inc.): 2 (https://510kreport.com/company/bard-access-systems-cr-bard)
- Bard Peripheral Vascular, Inc.: 2 (https://510kreport.com/company/bard-peripheral-vascular)

## Its most-cited devices
- K190527: GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters (2020), cited by 3
- K112791: Sitescrub Ipa Device (2012), cited by 2
- K182281: Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech (2018), cited by 2
- K172571: ULTRASCORE Focused Force PTA Balloon (2017), cited by 1
- K151177: XenMatrix AB Surgical Graft (2015), cited by 1
- K170294: VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 10cm x 15cm (4”x 6”) Ellipse,  VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm (6”) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 20cm (6”x8”) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 25cm (6”x10”) Oval (2017), cited by 1

## Recent decisions
- K190527: GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters (Mar 5, 2020)
- K182281: Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech (Oct 24, 2018)
- K172571: ULTRASCORE Focused Force PTA Balloon (Sep 22, 2017)
- K170294: VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 10cm x 15cm (4”x 6”) Ellipse,  VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm (6”) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 20cm (6”x8”) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 25cm (6”x10”) Oval (May 1, 2017)
- K162193: XenMatrix AB Surgical Graft (Dec 23, 2016)
- K151177: XenMatrix AB Surgical Graft (Jul 30, 2015)
- K142818: Phasix Mesh (Mar 31, 2015)
- K140501: Xenmatrix Surgical Graft (Apr 28, 2014)

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