# K072157: Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply)

- Pathway: 510(k) (Special)
- Applicant: Ohmeda Medical
- Decided: Aug 27, 2007 after 24 days
- Product code: FMT (Warmer, Infant Radiant)
- Device class: 2
- Regulation: 21 CFR 880.5130
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K962603 (1997). 21 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K070377: Giraffe and Panda Warmer, Ohmeda Medical (2007) Summary page 1.

## Most influential descendants
- K090697: Modification to: Giraffe and Panda Warmer (2009), 1 descendant of its own
- K123309: Giraffe and Panda Warmers (2013), 0 descendants of its own

## Recalls of this device
- Nov 18, 2016 · Class II · Z-1507-2017: 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

## 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.

Source page: https://510kreport.com/device/K072157
Methodology: https://510kreport.com/methodology