510(k) Report

FDA applicant

Marquette Medical Systems, Inc.

Milwaukee, WI9 decisions1997–19994 recalls

FDA records 9 decisions for Marquette Medical Systems, Inc. (Milwaukee, WI) from 1997 to 1999: 9 510(k) clearances. Most are in product codes LOS (Unnamed device) and DQA (Oximeter). Its devices cite 18 predicates, 0 of them its own earlier devices. 4 recalls are linked to its devices.

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

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Marquette Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

1in 2009

2008: 32009: 1
2007high 3 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • LOSUnnamed device4decisions
  • DQAOximeter1decision
  • HGMSystem, Monitoring, Perinatal1decision
  • DSACable, Transducer And Electrode, Patient, (Including Connector)1decision
  • CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase1decision
  • DSIDetector And Alarm, Arrhythmia1decision

Whose devices does it build on?

Its devices cite 18 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 17 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.

  • K980582Multi-Link Cable and Lead Wire SystemsMarquette Medical Systems, Inc. · 19986cite it
  • K993008Quantitative Sentinel SystemMarquette Medical Systems, Inc. · 19993cite it
  • K973403Cardiosmart STMarquette Medical Systems, Inc. · 19982cite it
  • K981024QT Dispersion and T Wave Analysis Program (QT Guard Analysis System)Marquette Medical Systems, Inc. · 19982cite it
  • K980299Apex OximeterMarquette Medical Systems, Inc. · 19981cites it
  • K974199Acute Cardiac Ischemia Time-Insensitive Predictive Instrument (Aci-Tipi) OptionMarquette Medical Systems, Inc. · 19981cites it

What has FDA decided for it lately?

  • K993008Quantitative Sentinel SystemMarquette Medical Systems, Inc. · 19993 recalls
  • K981024QT Dispersion and T Wave Analysis Program (QT Guard Analysis System)Marquette Medical Systems, Inc. · 1998
  • K980495Muse Cardiovascular Information SystemMarquette Medical Systems, Inc. · 1998
  • K980299Apex OximeterMarquette Medical Systems, Inc. · 19981 recall
  • K980582Multi-Link Cable and Lead Wire SystemsMarquette Medical Systems, Inc. · 1998
  • K973403Cardiosmart STMarquette Medical Systems, Inc. · 1998
  • K974199Acute Cardiac Ischemia Time-Insensitive Predictive Instrument (Aci-Tipi) OptionMarquette Medical Systems, Inc. · 1998
  • K973984Rac 2A Module HousingMarquette Medical Systems, Inc. · 1998

All 9 as Marquette Medical Systems, Inc. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K980299GE ApexPro Oximeter systems (ApexPro CH or ApexPro FH with ApexPro Telemetry version 3.9…Sep 25, 2009
  • K993008Centricity Perinatal (formerly Quantitative Sentinel) System - Fluid Total Precision…Sep 25, 2008
  • K993008GE Healthcare Centricity Perinatal (formerly Quantitative Sentinel) System - Alert and…Sep 25, 2008
  • K993008GE Healthcare Centricity Perinatal (formerly QS) System - PFILS (Patient File Server)…Jun 30, 2008

Other applicant names beginning “Marquette”

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

Marquette Electronics, Inc. 82Marquette Medical, Inc. 17Marquette Gas Analysis Corp. 2