510(k) Report

FDA applicant

Marquest Medical Products, Inc.

Englewood, CO32 decisions1980–20050 recalls

FDA records 32 decisions for Marquest Medical Products, Inc. (Englewood, CO) from 1980 to 2005: 32 510(k) clearances. Most are in product codes CBT (Arterial Blood Sampling Kit) and CAH (Filter, Bacterial, Breathing-Circuit). Its devices cite 11 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

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

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

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

FDA decisions per year

No FDA decision for Marquest Medical Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Marquest Medical Products, 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?

  • CBTArterial Blood Sampling Kit8decisions
  • CAHFilter, Bacterial, Breathing-Circuit4decisions
  • BTTHumidifier, Respiratory Gas, (Direct Patient Interface)4decisions
  • CAICircuit, Breathing (W Connector, Adaptor, Y Piece)4decisions
  • CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase3decisions
  • DQAOximeter2decisions

Also: BSJ (1), DWJ (1), JJS (1), IYT (1), KPD (1), BZE (1).

Whose devices does it build on?

Its devices cite 11 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 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.

  • K903138Marquest SCT 3000, Heated Humidification SystemMarquest Medical Products, Inc. · 19903cite it
  • K904690Temp Marq (TM) Convective Warming SystemMarquest Medical Products, Inc. · 19912cite it
  • K863918Minolta/Marquest Pulsox-7 Oxygen Saturation Monit.Marquest Medical Products, Inc. · 19871cites it
  • K962223Water Chambers for ST 3000 Heated HumidifierMarquest Medical Products, Inc. · 19971cites it
  • K962220Heated Wire Circuits for SCT 3000 Heated HumidifierMarquest Medical Products, Inc. · 19971cites it

What has FDA decided for it lately?

  • K050066C-CO2 Colorimetric CO2 IndicatorMarquest Medical Products, Inc. · 2005
  • K970478SCT 3000 Heated HumidifierMarquest Medical Products, Inc. · 1997
  • K962223Water Chambers for ST 3000 Heated HumidifierMarquest Medical Products, Inc. · 1997
  • K962220Heated Wire Circuits for SCT 3000 Heated HumidifierMarquest Medical Products, Inc. · 1997
  • K961838Respirgard II, SpirogardMarquest Medical Products, Inc. · 1996
  • K960972Disposable Gas Sampling Interface KitsMarquest Medical Products, Inc. · 1996
  • K904690Temp Marq (TM) Convective Warming SystemMarquest Medical Products, Inc. · 1991
  • K903138Marquest SCT 3000, Heated Humidification SystemMarquest Medical Products, Inc. · 1990

All 32 as Marquest Medical Products, Inc. →