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510(k) K101589

BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS by Cincinnati Sub-Zero Products, Inc. — Product Code DWJ

K101589 is an FDA 510(k) premarket notification submitted by Cincinnati Sub-Zero Products, Inc. for the device "BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS". The FDA issued a decision of Substantially Equivalent on September 20, 2010. The device falls under product code DWJ (System, Thermal Regulating), a Class II device regulated under 21 CFR 870.5900. Cincinnati Sub-Zero Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2010
Date Received
June 7, 2010
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 Cincinnati Sub-Zero Products, Inc.

  • K123946 — WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS (January 17, 2013)
  • K122813 — HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM (December 18, 2012)
  • K121669 — WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS) (July 3, 2012)
  • K120081 — NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS (February 17, 2012)
  • K110104 — BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM (February 4, 2011)
  • K101148 — WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS (October 1, 2010)
  • K072621 — ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE (December 13, 2007)
  • K070339 — DISPOSABLE TEMPERATURE PROBES/SENSORS AND INSTRUMENT CABLES (September 26, 2007)
  • K942790 — WARM AIR HYPERTHEERMIA SYSTEM (MODELS #130 AND #133) (January 24, 1995)
  • K942599 — WARM AIR WARMING UNIT (January 24, 1995)

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