# Carefusion 303, Inc.

- Location (FDA's records): San Diego, CA
- FDA decisions: 7 (2011–2025): 7 510(k) clearances
- Product codes: FRN (4), DRG (1), FPA (1), DSA (1)
- 510(k) review time since 2016: median 171 days, against 206 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 15 (2 its own); citations of its devices by later devices: 5 (2 its own)
- Recalls linked to its devices: 81 (32 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cardinal Health 303,Inc.: 3 (https://510kreport.com/company/cardinal-health-303)
- Alaris Medical Systems, Inc.: 3 (https://510kreport.com/company/alaris-medical-systems)
- Philips Medical Systems, Inc.: 1 (https://510kreport.com/company/philips-medical-systems)
- Nihon Kohden America, Inc.: 1 (https://510kreport.com/company/nihon-kohden-america)
- Care Fusion: 1 (https://510kreport.com/company/care-fusion)
- Cardinal Health, Alaris Products: 1 (https://510kreport.com/company/cardinal-health-alaris-products)
- Imed Corp.: 1 (https://510kreport.com/company/imed)
- Marquette Medical Systems, Inc.: 1 (https://510kreport.com/company/marquette-medical-systems)

## Firms that cite its devices most
- Vitalconnect, Inc.: 1 (https://510kreport.com/company/vitalconnect)
- Vyaire Medical, Inc.: 1 (https://510kreport.com/company/vyaire-medical)
- Fresenius Kabi AG: 1 (https://510kreport.com/company/fresenius-kabi)

## Its most-cited devices
- K133532: Alaris System with Guardrails Suite MX (2014), cited by 2
- K110809: Wireless Monitoring System (2011), cited by 1
- K211218: BD Alaris System with Guardrails Suite MX v12.1.2 (2023), cited by 1
- K163316: Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System (2017), cited by 1

## Recent decisions
- K243855: BD Alaris Infusion System with Guardrails Suite MX (Apr 25, 2025)
- K211218: BD Alaris System with Guardrails Suite MX v12.1.2 (Jul 21, 2023)
- K171957: MaxZero Extension Sets with Needless Connector (Jul 19, 2017)
- K163316: Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System (Jun 22, 2017)
- K133532: Alaris System with Guardrails Suite MX (Aug 21, 2014)
- K110535: Alaris PC Unit Module 8000 with Software Correction (Mar 26, 2012)
- K110809: Wireless Monitoring System (Jul 5, 2011)

Source page: https://510kreport.com/company/carefusion-303