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510(k) K921165

BAIR HUGGER TORSO BLANKET - ARMS IN MODEL 540 by Augustine Medical, Inc. — Product Code DWJ

K921165 is an FDA 510(k) premarket notification submitted by Augustine Medical, Inc. for the device "BAIR HUGGER TORSO BLANKET - ARMS IN MODEL 540". The FDA issued a decision of Substantially Equivalent on August 6, 1992. The device falls under product code DWJ (System, Thermal Regulating), a Class II device regulated under 21 CFR 870.5900. Augustine Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 1992
Date Received
March 11, 1992
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 Augustine Medical, Inc.

  • K021473 — BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM (July 9, 2002)
  • K020077 — MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX (January 31, 2002)
  • K001149 — AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MO (September 6, 2000)
  • K973741 — BAIR HUGGER BLOOD/FLUID WARMER (April 30, 1998)
  • K964673 — BAIR HUGGER MODEL 630 CARDIAC BLANKET (June 26, 1997)
  • K963293 — AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX (March 28, 1997)
  • K963672 — MODEL 90022 ROLLING STAND (January 6, 1997)
  • K960167 — SYSTEM, THERMAL REGULATING 74-DWJ (June 17, 1996)
  • K954446 — AUGUSTINE INTUBATION GUIDE (December 29, 1995)
  • K952864 — BAIR HUGGER MODEL 655 BLANKET (September 12, 1995)

Other clearances for product code DWJ

  • K262089 — Disposable Warming Blanket (August 21, 2026)
  • K261437 — Mistral-Air® Warming System (August 7, 2026)
  • 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)

FDA data resources