Modification to Augustine Medical Wound Care System, Model 68XXX

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K020077 ↗

FDA Product Code

MSA

Device Class

Class I

Regulation

21 CFR Part 878.4020

Advisory Committee

General, Plastic Surgery

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. →