# K201628: Panda iRes Warmer, Giraffe Warmer

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Feb 12, 2021 after 241 days
- Product code: FMT (Warmer, Infant Radiant)
- Device class: 2
- Regulation: 21 CFR 880.5130
- Recalls of this device: 3 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K101804 (2010). 2 ancestors in all.
No later device cites it as a predicate yet.
3 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122267: Giraffe and Panda Warmers, Ohmeda Medical, A Division of Datex-Ohmeda, Inc. (2012) Summary page 4.

## Recalls of this device
- May 8, 2026 · Class I · Z-2358-2026: Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, poten
- Aug 9, 2024 · Class II · Z-3080-2024: GE HealthCare has become aware that complete electrical safety testing was not conducted during manufacturing of certain Giraffe and Panda iRes Warmers. There are multiple electrical safety protection
- Aug 9, 2024 · Class II · Z-3081-2024: GE HealthCare has become aware that complete electrical safety testing was not conducted during manufacturing of certain Giraffe and Panda iRes Warmers. There are multiple electrical safety protection

## Indications for use
Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermoregulate 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 (Sp02) 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/K201628
Methodology: https://510kreport.com/methodology