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Giraffe and Panda Warmers

by Ohmeda Medical, A Division of Datex-Ohmeda, Inc. 2 variants

510(k) K122267

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

9 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK122267 Date2 Oct 2012ClearedStatusActive

Recalls

9 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-0484-2019 FDA Class II initiated 25 Sep 2018
    • Terminated Z-0481-2019 FDA Class II initiated 25 Sep 2018
    • Terminated Z-0482-2019 FDA Class II initiated 25 Sep 2018
    • Terminated Z-0483-2019 FDA Class II initiated 25 Sep 2018

    Potential electric leakage affecting the user.

  • 4 recalls, same reason

    • Terminated Z-1549-2014 FDA Class II initiated 2 Apr 2014
    • Terminated Z-1550-2014 FDA Class II initiated 2 Apr 2014
    • Terminated Z-1547-2014 FDA Class II initiated 2 Apr 2014
    • Terminated Z-1548-2014 FDA Class II initiated 2 Apr 2014

    Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver.

    • Terminated Z-1072-2014 FDA Class I initiated 1 Oct 2013 on shared 510(k) K122267

    Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FMT
Device Class
Class II
Regulation
21 CFR Part 880.5130
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Giraffe and Panda Warmers are infant radiant warmers designed to provide infrared heat in a controlled manner for neonatal care. These devices are classified as Class II medical devices under FDA regulation 880.5130 and are identified by the product code FMT.

The Giraffe and Panda Warmers received FDA 510(k) clearance (K122267) on October 2, 2012, following a 64-day review. They are manufactured by Ohmeda Medical, a division of Datex-Ohmeda, Inc., located in Laurel, Maryland, and are intended for use in general hospital settings.

Other devices from Ohmeda Medical, A Division of Datex-Ohmeda, Inc.

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Giraffe and Panda Warmer used for?

    The Giraffe and Panda Warmers are infant radiant warmers designed to provide infrared heat in a controlled manner for neonatal care, intended for use in general hospital settings to maintain infant body temperature.

  • How is the Giraffe and Panda Warmer supplied and is it sterile or reusable?

    The Giraffe and Panda Warmers are supplied as non-sterile, reusable medical devices intended for multiple patient use after proper cleaning and disinfection between uses, as they are designed for repeated use in hospital environments.

  • What regulatory pathway was used for the Giraffe and Panda Warmer?

    The Giraffe and Panda Warmers received FDA 510(k) clearance under submission K122267 on October 2, 2012, demonstrating substantial equivalence to a legally marketed predicate device under Class II regulations for infant radiant warmers.