Temp Marq Convective Warming System

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Temp Marq(Tm) Convective Warming System

510(k) Number

K904690 ↗

FDA Product Code

DWJ

Device Class

Class II

Regulation

21 CFR Part 870.5900

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Circuit Breathing

  Class I

  FDA 510(k) K840740 Active Cleared 17 Apr 1984

• Dispos. Anesthesia Face Mask

  Class I

  FDA 510(k) K840535 Active Cleared 21 Feb 1984

• Disposable Non-Rebreathing Anes. Circuit

  Class I

  FDA 510(k) K823714 Active Cleared 7 Jan 1983

• Marquest Sct 2000, Heated Humidification System

  Class II

  FDA 510(k) K880979 Active Cleared 15 Jul 1988

• C-CO2 Colorimetric CO2 Indicator

  Class II

  FDA 510(k) K050066 Active Cleared 1 Mar 2005

• Disposable Anesthesia Breathing Circuit

  Class I

  FDA 510(k) K822379 Active Cleared 20 Aug 1982

See all devices from Marquest Medical Products, Inc. →

• What clinical environments is the Temp Marq™ Convective Warming System designed for use in?

  The Temp Marq™ Convective Warming System is specifically designed for clinical settings where patient temperature regulation is critical, such as operating rooms, recovery areas, or intensive care units. Its purpose is to maintain or increase patient body temperature during medical procedures where hypothermia risk may occur.

• Is the Temp Marq™ Convective Warming System intended for single-use or reusable applications?

  The Temp Marq™ Convective Warming System is supplied as a reusable device, meaning it is intended to be cleaned, disinfected, and reused for multiple patients, provided proper maintenance protocols are followed.

• How is the regulatory status of the Temp Marq™ Convective Warming System determined?

  The device holds FDA 510(k) clearance (K904690) under the classification of a Class II medical device (product code DWJ), demonstrating substantial equivalence to a predicate device. It was reviewed by the FDA’s Cardiovascular (CV) Advisory Committee and is regulated under 21 CFR 870.5900 for thermal regulating systems.

• What types of procedures or patient populations would benefit most from using this warming system?

  While the device is not explicitly tied to a specific indication, it is intended for patients undergoing procedures where thermal management is important—such as surgery, extended clinical interventions, or recovery phases—to prevent hypothermia. Its use is particularly relevant in settings where patient temperature stability is critical, like intraoperative care or intensive monitoring.

• How is the device manufactured and distributed, and who is the manufacturer?

  The Temp Marq™ Convective Warming System is manufactured by Marquest Medical Products, Inc. (headquartered at 11039 E. Lansing Cir., Englewood, CO 80112). It is supplied as a reusable device, meaning it requires proper cleaning and maintenance between uses, and is distributed for clinical use in operating rooms, recovery areas, or intensive care units.