# K122267: Giraffe and Panda Warmers

- Pathway: 510(k) (Special)
- Applicant: Ohmeda Medical, A Division of Datex-Ohmeda, Inc.
- Decided: Oct 2, 2012 after 64 days
- Product code: FMT (Warmer, Infant Radiant)
- Device class: 2
- Regulation: 21 CFR 880.5130
- Recalls of this device: 9 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K101804 (2010). 1 ancestor in all.
2 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)
- K101804: Giraffe and Panda Warmers, Ohmeda Medical, A Division of Datex-Ohmeda, Inc. (2010) Summary page 1.

## Most influential descendants
- 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.
- Apr 2, 2014 · Class II · Z-1547-2014: 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.
- Apr 2, 2014 · Class II · Z-1550-2014: 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.
- Apr 2, 2014 · Class II · Z-1549-2014: 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.
- Apr 2, 2014 · Class II · Z-1548-2014: 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.
- 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/K122267
Methodology: https://510kreport.com/methodology