Resuscitaire

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

510(k) Number

K830748 ↗

FDA Product Code

FMT

Device Class

Class II

Regulation

21 CFR Part 880.5130

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Sp 120 Sophisticate

  Class I

  FDA 510(k) K802251 Active Cleared 23 Oct 1980

• Neocare Baby-Controlled Incubator

  Class II

  FDA 510(k) K813238 Active Cleared 22 Jan 1982

• Treonic IP5

  Class II

  FDA 510(k) K830936 Active Cleared 12 Apr 1983

• Peep/Cpap Valve

  Class II

  FDA 510(k) K781332 Active Cleared 4 Oct 1978

• Laboratory Data Mgmt System Sdms

  Class I

  FDA 510(k) K831838 Active Cleared 24 Jan 1984

• Neocare Oxygen Monitor

  Class II

  FDA 510(k) K810571 Active Cleared 11 Mar 1981

See all devices from Vickers America Medical Corp. →

• What is the Resuscitaire used for?

  The Resuscitaire is designed to provide thermal support to newborns requiring resuscitation or stabilization in general hospital settings, functioning as an infant radiant warmer to maintain body temperature during critical care.

• Who manufactures the Resuscitaire and where is it made?

  The Resuscitaire is manufactured by Vickers America Medical Corp., with the manufacturer's address listed as 803 N. Front St. Suite 3, McHenry, IL 60050, United States.

• What regulatory pathway was used for the Resuscitaire's market authorization?

  The Resuscitaire received FDA 510(k) clearance (K830748) on June 22, 1983, as substantially equivalent to a predicate device, following a traditional review process under FDA regulation 880.5130.

• Is the Resuscitaire intended for single-use or repeated use?

  The Resuscitaire is an infant radiant warmer designed for repeated use in clinical environments; it is not a single-use device but rather a durable piece of equipment intended for ongoing thermal support in hospital settings.

• What classification does the Resuscitaire hold under FDA regulations?

  The Resuscitaire is classified as a Class II medical device under FDA regulation 880.5130, which covers infant radiant warmers used for thermal support in general hospital settings.