# K971461: Servo-Control Wall-Mount Infant Warmer (IW980)/Manual-Control Wall-Mount Infant Warmer (IW990)

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Electronics, Ltd.
- Decided: Jul 16, 1997 after 86 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: 1 generation back to K921766 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921766: Ohio Infant Warmer System, Ohmeda Medical (1993) Summary page 1.

## Recalls of this device
- Nov 6, 2014 · Class II · Z-0210-2015: Breakage of the nut that secures the heater head in place, which can cause the heater head to become partially detached and swing towards the bassinet. There is the potential that a heater head could 

## Indications for use
The Fisher & Paykel Healthcare IW980 Servo-Control Wall-Mount Infant Warmer and IW990 Manual-Control Wall-Mount Infant Warmer are infant radiant warmers (as per 80 FMT, CFR §880.5130) containing an infrared heating element intended to be mounted over an infant in a pediatric hospital bed, to maintain the infant's body temperature by means of controlled radiant heat. The IWS980 and IW9S0 are designed to provide warmth to babies in the first few weeks of life, when an infant's self-thermoregulation capacity- may be reduced, or if external thermal support is required or desirable. This may include new-born babies in delivery room applications, including premature / low birth-weight infants, and support of critically ill babies in neonatal intensive care units (NICU's) or special care baby units (SCBU's). Situations which necessitate unobstructed access to an infant, including during resuscitation or surgical procedures, may indicate the need for a radiant heat source instead of equivalent support devices such as infant incubators.

Source page: https://510kreport.com/device/K971461
Methodology: https://510kreport.com/methodology