# Becton Dickinson Infusion Therapy Systems, Inc.

- Location (FDA's records): Sandy, UT
- FDA decisions: 36 (1997–2026): 36 510(k) clearances
- Product codes: FOZ (30), JKA (2), FPA (2), DBY (1), DYB (1)
- 510(k) review time since 2016: median 97 days, against 122 for FDA's reviews in the same codes and years (10 of 16 faster)
- Predicates its devices cite: 26 (17 its own); citations of its devices by later devices: 57 (17 its own)
- Recalls linked to its devices: 36 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Becton, Dickinson & CO: 4 (https://510kreport.com/company/becton-dickinson)
- Velano Vascular: 1 (https://510kreport.com/company/velano-vascular)
- Becton, Dickinson and Company (BD): 1 (https://510kreport.com/company/becton-dickinson-and-company-bd)
- Icu Medical, Inc.: 1 (https://510kreport.com/company/icu-medical)
- Deseret Medical, Inc.: 1 (https://510kreport.com/company/deseret-medical)
- Parke-Davis Co.: 1 (https://510kreport.com/company/parke-davis)

## Firms that cite its devices most
- Becton, Dickinson & CO: 5 (https://510kreport.com/company/becton-dickinson)
- Access Scientific, Inc.: 3 (https://510kreport.com/company/access-scientific)
- Togo Medikit Co., Ltd.: 2 (https://510kreport.com/company/togo-medikit)
- Becton, Dickinson and Company (BD): 2 (https://510kreport.com/company/becton-dickinson-and-company-bd)
- Hdc Corp.: 1 (https://510kreport.com/company/hdc)
- PAJUNK GmbH Medizintechnologie: 1 (https://510kreport.com/company/pajunk-medizintechnologie)
- Eastern Medikit, Ltd.: 1 (https://510kreport.com/company/eastern-medikit)
- A.B. Korkor Medical, Inc.: 1 (https://510kreport.com/company/ab-korkor-medical)

## Its most-cited devices
- K032843: Nexiva Closed IV Catheter System (2004), cited by 8
- K102520: BD Nexiva Closed IV Catheter System (2011), cited by 7
- K013800: Insyte, Angiocath, Insyte Autoguard, Angiocath Autoguard, Autoguard Pro, Intima, and Saf-T-Intima Intravascular Cathete (2001), cited by 7
- K020834: BD Introsyte Precision Introducer; BD Introsyte-N Precision Introducer; BD Introsyte Autoguard Shielded Introducer; BD I (2002), cited by 5
- K183399: BD Nexiva Closed IV Catheter System (2019), cited by 4
- K013304: BD Introsyte Precision Introducer, BD Introsyte Autogaurd Shielded Introducer (2002), cited by 4

## Recent decisions
- K252137: BD Insyte™ IV Catheter (Apr 2, 2026)
- K251422: BD Saf-T-Intima™ Subcutaneous Catheter System (Oct 8, 2025)
- K243403: BD Nexiva™ Closed IV Catheter System (Jul 25, 2025)
- K251155: BD Cathena™ Safety IV Catheter (Jul 11, 2025)
- K251654: BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter (Jun 27, 2025)
- K250682: BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector (Jun 3, 2025)
- K241586: PIVO™ Pro Needle-free Blood Collection Device (Feb 27, 2025)
- K233529: BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector (Dec 1, 2023)

Source page: https://510kreport.com/company/becton-dickinson-infusion-therapy-systems