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Warmtouch Patient Warming System, Model 5300

by Nellcor Puritan Bennett, Inc. 510(k)

Active United States

510(k) K020604

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK020604 Date23 Apr 2002ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DWJ
Device Class
Class II
Regulation
21 CFR Part 870.5900
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

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

The Warmtouch Patient Warming System, Model 5300, is a thermal regulating system designed to provide convective air warming. It is intended to assist in the prevention and treatment of hypothermia in patients.

This device is authorized under FDA 510(k) clearance. It is categorized as a Class 2 medical device under regulation number 870.5900.

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