# K101804: Giraffe and Panda Warmers

- Pathway: 510(k) (Special)
- Applicant: Ohmeda Medical, A Division of Datex-Ohmeda, Inc.
- Decided: Jul 21, 2010 after 23 days
- Product code: FMT (Warmer, Infant Radiant)
- Device class: 2
- Regulation: 21 CFR 880.5130
- Recalls of this device: 5 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
4 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Giraffe and Panda Warmers: named in the summary without a submission number

## Most influential descendants
- K122267: Giraffe and Panda Warmers (2012), 2 descendants of its own
- K201628: Panda iRes Warmer, Giraffe Warmer (2021), 0 descendants of its own
- K123309: Giraffe and Panda Warmers (2013), 0 descendants of its own

## Recalls of this device
- Sep 25, 2018 · Class II · Z-0482-2019: Potential electric leakage affecting the user.
- Sep 25, 2018 · Class II · Z-0481-2019: Potential electric leakage affecting the user.
- Sep 25, 2018 · Class II · Z-0483-2019: Potential electric leakage affecting the user.
- Sep 25, 2018 · Class II · Z-0484-2019: Potential electric leakage affecting the user.
- Oct 1, 2013 · Class I · Z-1072-2014: Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.

## Indications for use
Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment. An optional integrated SpO2 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor). An optional integrated resuscitation system may be used to provide the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant.

Source page: https://510kreport.com/device/K101804
Methodology: https://510kreport.com/methodology