510(k) Report

FDA applicant

Cardinal Health, Alaris Products

San Diego, CA9 decisions2005–200733 recalls

FDA records 9 decisions for Cardinal Health, Alaris Products (San Diego, CA) from 2005 to 2007: 9 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and FRN (Pump, Infusion). Its devices cite 13 predicates, 1 of them its own earlier devices. 33 recalls are linked to its devices, 10 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 Cardinal Health, Alaris Products’s devices, and how often a recall has named them.

FDA decisions per year

2in 2007

2007: 2
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2026

2007: 12009: 42010: 22011: 12012: 1, 1 Class I2013: 4, 3 Class I2015: 22016: 42017: 12020: 3, 3 Class I2021: 22023: 3, 3 Class I2025: 32026 (partial year): 1
2007high 4 (2009) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Cardinal Health, Alaris Products by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cardinal Health, Alaris Products’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?

  • FPASet, Administration, Intravascular2decisions
  • FRNPump, Infusion2decisions
  • FLLContinuous Measurement Thermometer1decision
  • LHISet, I.V. Fluid Transfer1decision
  • BRZSet, Blood Transfusion1decision
  • FMGStopcock, I.V. Set1decision

Also: FMF (1).

Whose devices does it build on?

Its devices cite 13 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 17 times; 1 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.

  • K061285Smartsite Needle Free Valve Administration SetsCardinal Health, Alaris Products · 20064cite it
  • K053049Alaris Safety Male LuerCardinal Health, Alaris Products · 20063cite it
  • K052790Smartsite Vented Vial Access Device, Model TBDCardinal Health, Alaris Products · 20053cite it
  • K051641Alaris System PC Unit, Model 8001Cardinal Health, Alaris Products · 20052cite it
  • K050230Turbo Temp TrioCardinal Health, Alaris Products · 20052cite it
  • K071108Texium SyringeCardinal Health, Alaris Products · 20072cite it

What has FDA decided for it lately?

  • K071400Smartsite StopcockCardinal Health, Alaris Products · 2007
  • K071108Texium SyringeCardinal Health, Alaris Products · 20071 recall
  • K061285Smartsite Needle Free Valve Administration SetsCardinal Health, Alaris Products · 20062 recalls
  • K053049Alaris Safety Male LuerCardinal Health, Alaris Products · 20063 recalls
  • K052790Smartsite Vented Vial Access Device, Model TBDCardinal Health, Alaris Products · 2005
  • K051641Alaris System PC Unit, Model 8001Cardinal Health, Alaris Products · 200510 Class I recalls
  • K050115Blood Hand Pump Administration SetCardinal Health, Alaris Products · 2005
  • K043590SE Infusion System with MMSCardinal Health, Alaris Products · 20051 recall

All 9 as Cardinal Health, Alaris Products →

What has been recalled?

33 recalls linked to its devices; the latest:

  • K023264BD Alaris" System with Guardrails" Suite MX with Point of Care UnitFeb 11, 2026Class II
  • K053049Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap…May 12, 2025Class II
  • K053049BD Texium Closed Male Luer with Female Cap, Ref: 10012241-0500May 12, 2025Class II
  • K071108BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, REF: MY8010…May 12, 2025Class II
  • K072105BD Alaris Syringe Module, REF 8110Sep 15, 2023Class I
  • K072105BD Alaris PCU REF 8015Sep 15, 2023Class I

Other applicant names beginning “Cardinal”

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

Cardinal Health, Inc. 28Cardinal Health200, LLC 26Cardinal Health-Medical Products and Services 6Cardinal Health 207, Inc. 5Cardinal Spine, LLC 4Cardinal Health 200, Inc. 4Cardinal Health 303,Inc. 4Cardinal Health Germany 234 GmbH 2Cardinal Scale Mfg. Co. 1