Birthing Room Warmer

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

510(k) Number

K871594 ↗

FDA Product Code

FMT

Device Class

Class II

Regulation

21 CFR Part 880.5130

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Infant Intensive Care System Vertical Height Adjus

  Class II

  FDA 510(k) K875270 Active Cleared 19 Jan 1988

• Watchchild Obsterical Patient Data Management System

  Class II

  FDA 510(k) K974248 Active Cleared 7 Oct 1998

• Isolette Incubator

  Class II

  FDA 510(k) K781876 Active Cleared 7 Dec 1978

• Duo-Lite Phototherapy System

  Class II

  FDA 510(k) K971256 Active Cleared 24 Sep 1997

• Monitoring System AS100-AS115 Record

  Class I

  FDA 510(k) K832754 Active Cleared 22 Dec 1983

• Rw Resucitaire Infant Radiant Warmer

  Class II

  FDA 510(k) K940951 Active Cleared 3 May 1995

See all devices from Air-Shields, Inc. →

• What is the Birthing Room Warmer used for?

  The Birthing Room Warmer is an infant radiant warmer designed for use during labor and delivery procedures. It provides warming therapy and integrates neonatal thermoregulation and respiratory support into a single device for use in general hospital settings.

• How is the Birthing Room Warmer supplied?

  The Birthing Room Warmer is supplied by Air-Shields, Inc. It is authorized under FDA 510(k) clearance K871594 with product code FMT and is classified as a Class II medical device intended for general hospital use.

• What is the regulatory status of the Birthing Room Warmer?

  The Birthing Room Warmer has received FDA 510(k) clearance K871594 with product code FMT. It is classified as a Class II medical device and is intended for use in general hospital settings. The device is substantially equivalent to other products in this category.

• Can the Birthing Room Warmer be reused or is it single-use?

  The device data does not specify whether the Birthing Room Warmer is designed for single-use or multiple uses. For information on reusability, sterilization requirements, or maintenance procedures, please consult the manufacturer's documentation or contact Air-Shields, Inc. directly.