Preemicare Series 2000 Infant Warmer

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

510(k) Number

K885350 ↗

FDA Product Code

FMT

Device Class

Class II

Regulation

21 CFR Part 880.5130

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Preemicare Model D1-X1, Series 3000

  Class II

  FDA 510(k) K881476 Active Cleared 8 Dec 1988

• Neonatal Environmental Monitor, Model 275

  Class II

  FDA 510(k) K891674 Active Cleared 31 Aug 1989

• Preemicare Model 200-Ii Infant Transport Ventil.

  Class II

  FDA 510(k) K893622 Active Cleared 3 Jan 1990

• Infant Ventilator

  Class II

  FDA 510(k) K911450 Active Cleared 18 Jun 1991

• Preemicare Nebutech Nebulizer System

  Class II

  FDA 510(k) K896375 Active Cleared 29 Oct 1990

• Preemicare Model 2500 Transport Warmer

  Class II

  FDA 510(k) K893624 Active Cleared 27 Sep 1989

See all devices from Preemicare Corp. →

• What is the Preemicare Series 2000 Infant Warmer used for?

  The Preemicare Series 2000 Infant Warmer is used for warming infants in general hospital settings, as indicated by its classification as a warmer, infant radiant device.

• Is the Preemicare Series 2000 Infant Warmer a single-use device?

  No, the Preemicare Series 2000 Infant Warmer is a non-single use device, and its storage and usage are subject to the manufacturer's instructions.

• What configurations is the Preemicare Series 2000 Infant Warmer available in?

  The device is available in various configurations, but specific details are not provided and should be obtained from the manufacturer.

• What regulatory clearance has the Preemicare Series 2000 Infant Warmer received?

  The Preemicare Series 2000 Infant Warmer has been granted FDA 510K clearance with the number K885350, indicating it is substantially equivalent to a predicate device.