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510(k) K904690

TEMP MARQ(TM) CONVECTIVE WARMING SYSTEM by Marquest Medical Products, Inc. — Product Code DWJ

K904690 is an FDA 510(k) premarket notification submitted by Marquest Medical Products, Inc. for the device "TEMP MARQ(TM) CONVECTIVE WARMING SYSTEM". The FDA issued a decision of Substantially Equivalent on February 1, 1991. The device falls under product code DWJ (System, Thermal Regulating), a Class II device regulated under 21 CFR 870.5900. Marquest Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 1991
Date Received
October 16, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Thermal Regulating
Device Class
Class II
Regulation Number
870.5900
Review Panel
CV
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Marquest Medical Products, Inc.

  • K050066 — C-CO2 COLORIMETRIC CO2 INDICATOR (March 1, 2005)
  • K970478 — SCT 3000 HEATED HUMIDIFIER (July 16, 1997)
  • K962220 — HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER (January 14, 1997)
  • K962223 — WATER CHAMBERS FOR ST 3000 HEATED HUMIDIFIER (January 14, 1997)
  • K960972 — DISPOSABLE GAS SAMPLING INTERFACE KITS (October 18, 1996)
  • K961838 — RESPIRGARD II, SPIROGARD (October 18, 1996)
  • K903138 — MARQUEST SCT 3000, HEATED HUMIDIFICATION SYSTEM (October 11, 1990)
  • K902632 — GAS-LYTE 1CC AND 3CC ARTERIAL BLOOD SAMPLERS (September 4, 1990)
  • K903307 — TEMP MARQ TEMPERATURE TREND INDICATOR (August 17, 1990)
  • K880979 — MARQUEST SCT 2000, HEATED HUMIDIFICATION SYSTEM (July 15, 1988)

Other clearances for product code DWJ

  • K260278 — ThermAffyx(TM) Patient Safety System (July 8, 2026)
  • K260903 — Hot Pink Pad Warming System (April 16, 2026)
  • K252861 — Warming System (April 7, 2026)
  • K251974 — Arctic Sun Temperature Management System (Model 5000) (October 24, 2025)
  • K242964 — Celsi Warmer (June 20, 2025)
  • K243942 — Arctic Sun Stat Temperature Management System (April 30, 2025)
  • K232627 — HotDog Warming Mattress + Return Electrode (April 18, 2024)
  • K232502 — Cocoon Convective Warming System, Model CWS7000 (February 21, 2024)
  • K231211 — Medline ComfortTemp Patient Warming System (December 1, 2023)
  • K232638 — FilteredFlo Warming Blankets (October 24, 2023)

FDA data resources