# K022609: Surgical Patient Warmer, Model PW820 Jhu

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: Mar 6, 2003 after 212 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: 2 generations back to K871179 (1987). 4 ancestors in all.
295 later devices descend from it; 1 cites it directly.
0 of 300 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982636: Patient Warmer- Model PW810, Fisher & Paykel Healthcare, Ltd. (1998) Summary page 1.

## Most influential descendants
- 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
- K070388: Profile Multi-Platform System (2007), 129 descendants of its own

## Indications for use
The Fisher & Paykel Healthcare PW820 Surgical Patient Warmer is an Infra-red lamp. It emits energy at infra-red frequencies to provide topical heating. The PW820 is intended primarily for use in the operating room in order to alleviate patient body-core cooling induced by the use of anesthetic drugs and the operating room environment. Additionally, the PW820 may also be used to provide topical heating in other clinical situations where unobstructive external thermal support for patients is required (for example, post-operative recovery, hypothermia recovery, ICU). The PW820 is operated at a fixed skin surface temperature setting of either 41°C or 37°C. The setting of 41°C is intended for adult patients under general anesthetic. The setting of 37°C is intended for pediatric and infant patients and for non-anesthetised adults. The PW820 is for use with infants only during surgery.

Source page: https://510kreport.com/device/K022609
Methodology: https://510kreport.com/methodology