510(k) Report

FDA applicant

Alaris Medical Systems, Inc.

San Diego, CA16 decisions1998–200428 recalls

FDA records 16 decisions for Alaris Medical Systems, Inc. (San Diego, CA) from 1998 to 2004: 16 510(k) clearances. Most are in product codes FRN (Pump, Infusion) and MEA (Pump, Infusion, Pca). Its devices cite 18 predicates, 4 of them its own earlier devices. 28 recalls are linked to its devices, 9 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 Alaris Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Alaris Medical Systems, Inc. since 2007.

Recalls per year

2in 2026

2008: 32009: 42013: 1, 1 Class I2015: 2, 1 Class I2016: 12017: 22019: 12020: 4, 4 Class I2023: 32024: 12025: 2, 2 Class I2026 (partial year): 2, 1 Class I
2007high 4 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Alaris Medical Systems, 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, Infusion7decisions
  • MEAPump, Infusion, Pca2decisions
  • DQAOximeter2decisions
  • FPASet, Administration, Intravascular1decision
  • OLWIndex-Generating Electroencephalograph Software1decision
  • CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase1decision

Also: LHI (1), DXH (1).

Whose devices does it build on?

Its devices cite 18 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 33 times; 4 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.

  • K030459Medley System with Medication Management System (MMS)Alaris Medical Systems, Inc. · 20039cite it
  • K012383Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE), Medsystem Iii Infusion (Msiii)…Alaris Medical Systems, Inc. · 20014cite it
  • K013087Single Dose Dispensing Pin, Model 2201Alaris Medical Systems, Inc. · 20014cite it
  • K023264Medley Syringe Pump Module System, Model 8110Alaris Medical Systems, Inc. · 20024cite it
  • K032233Medley Pca Module, Model 8120Alaris Medical Systems, Inc. · 20033cite it
  • K041241Medley System with Bar Code Module, Model 8600Alaris Medical Systems, Inc. · 20042cite it

What has FDA decided for it lately?

  • K043299Medley Pca Module, Model 8120Alaris Medical Systems, Inc. · 20041 Class I recall
  • K041241Medley System with Bar Code Module, Model 8600Alaris Medical Systems, Inc. · 20041 Class I recall
  • K031741Medley ETCO2 Module (Includes Accessories), Model 8300Alaris Medical Systems, Inc. · 20042 recalls
  • K032233Medley Pca Module, Model 8120Alaris Medical Systems, Inc. · 20033 recalls
  • K032147Signature Edition Infusion Pump, Signature Edition Administration Sets, Models 70XX, 71XX, 72XX, 7XXXX SeriesAlaris Medical Systems, Inc. · 20031 recall
  • K030459Medley System with Medication Management System (MMS)Alaris Medical Systems, Inc. · 2003
  • K023264Medley Syringe Pump Module System, Model 8110Alaris Medical Systems, Inc. · 20021 Class I recall
  • K022677Medley SPO2 Module, Model 8210 & SPO2 Sensors & CableAlaris Medical Systems, Inc. · 20022 recalls

All 16 as Alaris Medical Systems, Inc. →

What has been recalled?

28 recalls linked to its devices; the latest:

  • K022209BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD Alaris Pump…Aug 19, 2026Class I
  • K023264BD Alaris" System with Guardrails" Suite MX with Point of Care UnitFeb 11, 2026Class II
  • K022209BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing…Sep 11, 2025Class I
  • K022209BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, Back Check…Jul 8, 2025Class I
  • K022209Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y…Apr 18, 2024Class II
  • K022209BD Alaris Pump infusion sets (Product Name, Catalog #) BD AlarisTM Pump Infusion Set…Oct 11, 2023Class II