# K970432: Infant Radiant Warmer - Models IW910 and IW920

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Electronics, Ltd.
- Decided: May 7, 1997 after 92 days
- Product code: FMT (Warmer, Infant Radiant)
- Device class: 2
- Regulation: 21 CFR 880.5130
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
323 later devices descend from it; 1 cites it directly.
0 of 324 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K921766: Ohio Infant Warmer System, Ohmeda Medical (1993). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K982636: Patient Warmer- Model PW810 (1998), 322 descendants of its own
- K022609: Surgical Patient Warmer, Model PW820 Jhu (2003), 295 descendants of its own
- K033768: Altus Medical Optional Infrared Handpiece (2004), 294 descendants of its own
- K042165: Cutera Tabletop Aesthetic Product (2004), 241 descendants of its own
- K050370: Palomar Luxir Handpiece (2005), 239 descendants of its own

## 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 
- Oct 9, 2006 · Not classified · Z-0485-2007: This firm has received Product Complaint Reports concerning bending of the pivot plate. The elevator base of the CosyCot Infant Warmer incorporates a pivot plate which forms part of the mechanism allo

## Indications for use
The intended use of Infant Radiant Warmers is to provide thermal support for newborn babies in the first few weeks of life This may include in the delivery room in the period immediately after birth, and in the neonatal intensive care unit for critically ill babies which may require frequent intervention from hospital personnel.

Source page: https://510kreport.com/device/K970432
Methodology: https://510kreport.com/methodology