# K963058: Infant Warmer System

- Pathway: 510(k) (Traditional)
- Applicant: Ohmeda Medical
- Decided: Oct 1, 1996 after 56 days
- Product code: FMT (Warmer, Infant Radiant)
- Device class: 2
- Regulation: 21 CFR 880.5130
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
3 of 7 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) Ohmeda - Ohio Infant Warmer System: named in the summary without a submission number

## Most influential descendants
- K070377: Giraffe and Panda Warmer (2007), 3 descendants of its own
- K072157: Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply) (2007), 2 descendants of its own
- K121625: Lullaby TM Warmer (2012), 1 descendant of its own
- K090697: Modification to: Giraffe and Panda Warmer (2009), 1 descendant of its own
- K173516: NuBorne Infant Warmer (2018), 0 descendants of its own

## Recalls of this device
- May 5, 2017 · Class II · Z-2323-2017: GE Healthcare has recently become aware of a potential safety issue related to loose screws in the Heater Head of the Infant Warmer System (IWS). Hot screws from the Heater Head of the IWS could f
- Nov 18, 2016 · Class II · Z-1511-2017: 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
- Aug 4, 2016 · Class II · Z-1015-2017: GE Healthcare has recently become aware of a potential safety issue related to loose screws in the Heater Head of the Infant Warmer System (IWS). Hot screws from the Heater Head of the IWS could fall 

## 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 or necessitate external heat to smoothen the transition from the uterus to the external environment. They fulfill the same purpose of neonatal incubators but they may be preferred over incubators when total access to the patient is needed or desirable (e.g., surgical procedures, extracorporeal membrane oxygenation, frequent resuscitation, etc.). Most infant radiant warmers can be used in two operating modes: a) Manual: The clinician sets the appropriate heater output for maintaining the desired patient temperature. The heater output is initially selected based on the clinician’s training and experience and then is adjusted based on the patients’ needs and clinical status. b) Servo: The clinician sets the desired patient temperature. A skin temperature probe senses the patient temperature and feeds this information to the controller of the infant radiant warmer. The controller then adjusts the heater output to maintain the patient temperature at the set value. These adjustments to the heater output are made in such a way to gradually change the patient’s temperature while minimizing overshooting and patient stress. Infant radiant warmers have alarms to alert clinicians when certain patient or equipment conditions occur, such as a malfunction, or an excessive departure of the patient’s temperature from the set value. Infant radiant warmers may incorporate other features, such as phototherapy, observation light, tilting of the bed, and data output to remote monitors or nurse call systems.

Source page: https://510kreport.com/device/K963058
Methodology: https://510kreport.com/methodology