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Patient Warmer Model PW810

by Fisher & Paykel Healthcare, Inc.

510(k) K982636

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK982636 Date26 Oct 1998ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
ILY
FDA applicant
Fisher & Paykel Healthcare, Ltd.
Device class
Class II
Regulation
21 CFR Part 890.5500
Advisory committee
Physical Medicine
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Patient Warmer Model PW810 is an infrared lamp classified under product code ILY, designed to maintain patient body temperature through controlled radiant heat. It operates by emitting infrared energy to provide topical heating, mitigating excessive or undesirable heat loss in patients. This device is positioned above an operating table or patient bed to deliver thermal support during procedures or recovery.

The Patient Warmer Model PW810 is supplied as a reusable medical device and is intended for use in clinical settings such as operating rooms or recovery areas. It is not described as sterile but is regulated under FDA 510(k) clearance (K982636) with a decision classification of Substantially Equivalent. No specific MRI safety or sterility requirements are noted in the available data. The device is manufactured by Fisher & Paykel Healthcare, Ltd., with specifications aligned to 21 CFR §890.5500.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Fisher & Paykel PW810 Patient Warmer used for?

    The PW810 Patient Warmer is designed to maintain patient body temperature by delivering controlled radiant heat through infrared energy. It helps prevent excessive heat loss during medical procedures or recovery, ensuring thermal stability in clinical settings such as operating rooms or recovery areas.

  • Is the PW810 Patient Warmer reusable or single-use?

    The PW810 Patient Warmer is supplied as a reusable medical device. Unlike single-use items, it is intended for repeated use in clinical environments, provided it is properly cleaned and maintained between applications.

  • What regulatory clearance does the PW810 Patient Warmer hold?

    The PW810 Patient Warmer holds FDA 510(k) clearance under the classification of Substantially Equivalent (SESE), with a clearance number of K982636. This indicates it meets regulatory standards for safety and effectiveness as determined by the FDA’s Physical Medicine advisory committee.

  • How is the PW810 Patient Warmer positioned for use?

    The PW810 Patient Warmer is positioned above an operating table or patient bed to deliver targeted infrared heat. Its design ensures efficient thermal support while minimizing unnecessary heat exposure to surrounding areas.

  • Does the PW810 Patient Warmer require sterilization before use?

    The available data does not specify sterility requirements for the PW810 Patient Warmer. As a reusable device, it should be cleaned and maintained according to manufacturer guidelines, but it is not described as sterile or requiring sterilization before each use.