# K972885: Servo-Control Wall-Mount Cosycot Infant Warmer Model IW960, Manual Control Wall-Mount Cosycot Infant Warmer Model IW970

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Electronics, Ltd.
- Decided: Oct 30, 1997 after 86 days
- Product code: FMT (Warmer, Infant Radiant)
- Device class: 2
- Regulation: 21 CFR 880.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K892885 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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.
- K892885: Resubmitted RD1000 Neopuff Infant Resuscitator, Fisher & Paykel Electronics, Ltd. (1989) Summary page 1.

## Indications for use
The Fisher & Paykel Healthcare IW960 Servo-Control Wall-Mount CosyCot Infant Warmer and IW970 Manual-Control Wall-Mount CosyCot Infant Warmer are infant radiant warmers (as per 80 FMT, CFR §880.5130) containing an infrared heating element mounted above a built-in pediatric bed assembly, in order to maintain an infant's body temperature by means of controlled radiant heat. The IW960 and IW970 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 babv units (SCBLI's). Siteations which necessiteta unebstructed access to an infant, including during resuscitation or surgical procedures, may indicate ihe need for a radiant heat source instead of equivalent support devices such as infant incubators.

Source page: https://510kreport.com/device/K972885
Methodology: https://510kreport.com/methodology