Bair Hugger Torso Blanket – Arms In Model 540

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

510(k) Number

K921165 ↗

FDA Product Code

DWJ

Device Class

Class II

Regulation

21 CFR Part 870.5900

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Bair Hugger Model 630 Cardiac Blanket

  Class II

  FDA 510(k) K964673 Active Cleared 26 Jun 1997

• System, Thermal Regulating 74-Dwj

  Class II

  FDA 510(k) K960167 Active Cleared 17 Jun 1996

• Bair Hugger Cub Blanket- Short Model 536

  Class II

  FDA 510(k) K920432 Active Cleared 18 Jun 1992

• Augustine Guide Kit

  Class I

  FDA 510(k) K921166 Active Cleared 23 Apr 1992

• Bair Hugger Blood/Fluid Warmer Open recall

  Class II

  FDA 510(k) K973741 Active Cleared 30 Apr 1998

• Augustine Stylet

  Class I

  FDA 510(k) K910659 Active Cleared 17 May 1991

See all devices from Augustine Medical, Inc. →

• What is the primary purpose of the Bair Hugger Torso Blanket – Arms In Model 540, and how does it differ from other warming blankets?

  The Bair Hugger Torso Blanket – Arms In Model 540 is designed specifically to maintain patient body temperature during medical procedures by covering the torso while leaving the arms exposed. This targeted approach helps prevent hypothermia in patients undergoing surgery or invasive procedures, distinguishing it from full-body blankets that cover the arms. Its disposable, single-use nature ensures hygiene and reduces cross-contamination risks in clinical settings.

• Is the Bair Hugger Torso Blanket – Arms In Model 540 sterile, and how should it be stored before use?

  The Model 540 is supplied as a non-sterile device, meaning it is not pre-packaged in a sterile barrier. To maintain its integrity, it should be stored in a clean, dry environment away from direct sunlight or moisture before use. Always check the packaging for any expiration or damage indicators before application.

• Can this blanket be reused, or is it intended for single-use only?

  The Bair Hugger Torso Blanket – Arms In Model 540 is explicitly designed for single-use only. Reusing it could compromise patient safety by introducing contamination or reducing its thermal regulation effectiveness. Always adhere to the manufacturer’s instructions for proper disposal after one use.

• What regulatory pathway was followed for FDA clearance of this device, and what classification does it hold?

  The Model 540 was granted FDA 510(k) clearance (K921165) in 1992 under the Traditional 510(k) pathway, demonstrating it is substantially equivalent to prior devices. It is classified as a Class II device under FDA regulation 870.5900, indicating it poses moderate risk and requires special controls to ensure safety and effectiveness.

• How is this blanket integrated into the Bair Hugger System, and what clinical settings would benefit most from its use?

  The Torso Blanket – Arms In Model 540 is part of the Bair Hugger System, which combines forced-air warming technology with disposable blankets to regulate patient temperature. It is particularly useful in surgical and procedural settings where patients may be at risk of hypothermia due to exposure (e.g., during abdominal, thoracic, or orthopedic surgeries) but require arm access for monitoring or interventions. Its design ensures targeted warming without obstructing critical areas.