510(k) Report

FDA applicant

Cardinal Health 303,Inc.

San Diego, CA4 decisions2006–20095 recalls

FDA records 4 decisions for Cardinal Health 303,Inc. (San Diego, CA) from 2006 to 2009: 4 510(k) clearances. All are in product code FRN (Pump, Infusion). Its devices cite 4 predicates, 0 of them its own earlier devices. 5 recalls are linked to its devices, 3 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 303,Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2007: 22009: 1
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2026

2023: 4, 3 Class I2026 (partial year): 1
2007high 4 (2023) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Cardinal Health 303,Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cardinal Health 303,Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FRNPump, Infusion4decisions

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 0 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.

  • K091308Alaris PC Unit, Models 8000 and 8015Cardinal Health 303,Inc. · 20092cite it
  • K072105Alaris System with MMS, Model 8XXXCardinal Health 303,Inc. · 20071cites it

What has FDA decided for it lately?

  • K091308Alaris PC Unit, Models 8000 and 8015Cardinal Health 303,Inc. · 2009
  • K072105Alaris System with MMS, Model 8XXXCardinal Health 303,Inc. · 20073 Class I recalls
  • K070268Signature Edition Infusion System, Models 710X, 720XCardinal Health 303,Inc. · 2007
  • K063288Signature Edition Gold Infusion System, Model 7X3XCardinal Health 303,Inc. · 2006

All 4 as Cardinal Health 303,Inc. →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K023264BD Alaris" System with Guardrails" Suite MX with Point of Care UnitFeb 11, 2026Class II
  • K072105BD Alaris Syringe Module, REF 8110Sep 15, 2023Class I
  • K072105BD Alaris PCU REF 8015Sep 15, 2023Class I
  • K072105Alaris PCA Module 8120Sep 15, 2023Class I
  • K072105Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP…Jan 24, 2023Class II

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, Alaris Products 9Cardinal Health-Medical Products and Services 6Cardinal Health 207, Inc. 5Cardinal Spine, LLC 4Cardinal Health 200, Inc. 4Cardinal Health Germany 234 GmbH 2Cardinal Scale Mfg. Co. 1