# K982636: Patient Warmer- Model PW810

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: Oct 26, 1998 after 89 days
- Product code: ILY (Lamp, Infrared, Therapeutic Heating)
- Device class: 2
- Regulation: 21 CFR 890.5500
- 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 K871179 (1987). 3 ancestors in all.
322 later devices descend from it; 2 cite it directly.
0 of 326 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K871179: Opn Xii UL, Aragona AB Co. (1987) Summary page 1.
- K871178: MTC XI UL, Aragona Medical, Inc. (1987) Summary page 1.
- K970432: Infant Radiant Warmer - Models IW910 and IW920, Fisher & Paykel Electronics, Ltd. (1997) Summary page 1.

## Most influential descendants
- 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
- K080318: Alma Laser Nir Module (2008), 184 descendants of its own

## Indications for use
The Fisher & Paykel Healthcare PW810 Patient Warmer is an Infrared Lamp (as per 89 ILY, 21 CFR §890.5500) containing an infrared heating element to be positioned above an operating table or similar patient bed, in order to maintain a patient’s body temperature by means of controlled radiant heat. The PW810 is intended to provide topical heating to patients in clinical situations where external thermal support is required or desirable. This may include during or following surgical procedures, hypothermia recovery, and severe burns patients. Situations which necessitate unobstructed access to a patient may indicate the need for a radiant heat source, in preference to thermal regulation systems which rely on extensive surface contact with a patient. Minimal direct contact by a warming system may also be required for particular injuries to patients.

Source page: https://510kreport.com/device/K982636
Methodology: https://510kreport.com/methodology