# K090697: Modification to: Giraffe and Panda Warmer

- Pathway: 510(k) (Special)
- Applicant: Ohmeda Medical
- Decided: Apr 16, 2009 after 30 days
- Product code: FMT (Warmer, Infant Radiant)
- Device class: 2
- Regulation: 21 CFR 880.5130
- Recalls of this device: 6 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K962603 (1997). 22 ancestors in all.
1 later device descends from it; 1 cites it directly.
5 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072157: Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply), Ohmeda Medical (2007) Summary page 1.
- K070377: Giraffe and Panda Warmer, Ohmeda Medical (2007) Summary page 1.

## Most influential descendants
- 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.
- Nov 18, 2016 · Class II · Z-1508-2017: Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are referred to as Taller Bridge power cords. The overheating of the power cord could result in fi
- 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 an SP02 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. For professional use only, by trained clinicians.

Source page: https://510kreport.com/device/K090697
Methodology: https://510kreport.com/methodology