510(k) Report

FDA applicant

Carefusion 303, Inc.

San Diego, CA7 decisions2011–202581 recalls

FDA records 7 decisions for Carefusion 303, Inc. (San Diego, CA) from 2011 to 2025: 7 510(k) clearances. Most are in product codes FRN (Pump, Infusion) and DRG (Transmitters And Receivers, Physiological…). Since 2016 its 510(k)s took a median of 171 days from receipt to decision, against 206 for FDA’s reviews in the same codes and years. Its devices cite 15 predicates, 2 of them its own earlier devices. 81 recalls are linked to its devices, 32 Class I.

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

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Carefusion 303, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2011: 12012: 12014: 12017: 22023: 12025: 1
2011high 2 (2017) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2026

2018: 1, 1 Class I2019: 342020: 22, 16 Class I2021: 8, 8 Class I2023: 3, 3 Class I2024: 62025: 6, 4 Class I2026 (partial year): 1
2011high 34 (2019) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Carefusion 303, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Carefusion 303, 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?

  • FRNPump, Infusion4decisions
  • DRGTransmitters And Receivers, Physiological Signal, Radiofrequency1decision
  • FPASet, Administration, Intravascular1decision
  • DSACable, Transducer And Electrode, Patient, (Including Connector)1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 171 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 206 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 15 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 2 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.

  • K133532Alaris System with Guardrails Suite MXCarefusion 303, Inc. · 20142cite it
  • K110809Wireless Monitoring SystemCarefusion 303, Inc. · 20111cites it
  • K211218BD Alaris System with Guardrails Suite MX v12.1.2Carefusion 303, Inc. · 20231cites it
  • K163316Multi-Link X2 ECG Adapter and Direct Connect Lead Wire SystemCarefusion 303, Inc. · 20171cites it

What has FDA decided for it lately?

  • K243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, Inc. · 2025
  • K211218BD Alaris System with Guardrails Suite MX v12.1.2Carefusion 303, Inc. · 20237 Class I recalls
  • K171957MaxZero Extension Sets with Needless ConnectorCarefusion 303, Inc. · 201734 recalls
  • K163316Multi-Link X2 ECG Adapter and Direct Connect Lead Wire SystemCarefusion 303, Inc. · 2017
  • K133532Alaris System with Guardrails Suite MXCarefusion 303, Inc. · 201428 Class I recalls
  • K110535Alaris PC Unit Module 8000 with Software CorrectionCarefusion 303, Inc. · 2012
  • K110809Wireless Monitoring SystemCarefusion 303, Inc. · 2011

All 7 as Carefusion 303, Inc. →

What has been recalled?

81 recalls linked to its devices; the latest:

  • K023264BD Alaris" System with Guardrails" Suite MX with Point of Care UnitFeb 11, 2026Class II
  • K211218BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System…Nov 6, 2025Class II
  • K211218BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437…Oct 17, 2025Class I
  • K211218BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versionsJul 8, 2025Class I
  • K211218BD Alaris Systems Manager , REF 9601 Infusion Safety Management SoftwareFeb 18, 2025Class I
  • K211218BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management SoftwareFeb 18, 2025Class I

Other applicant names beginning “Carefusion”

FDA records each applicant name separately; these may or may not be the same firm.

Carefusion 2200, Inc. 14Carefusion Germany 234 GmbH 12Carefusion 209, Inc. 5Carefusion, Inc. 3Carefusion (Bd) 1