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Thera-Heat Heated Humidifier and Adult Dual and Single Limb Heated Wire Ventilator Breathing Circuits

by Smiths Medical Asd, Inc.

510(k) K071958

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 NumberK071958 Date21 Nov 2007ClearedStatusActive

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  • Withdrawn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
BTT
Device Class
Class II
Regulation
21 CFR Part 868.5450
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

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

This device is a heated humidifier and adult dual and single limb heated wire ventilator breathing circuit system. It is designed to warm and humidify breathing gases before they enter a patient's airway during mechanical ventilation.

The system is intended for use in hospitals and alternate sites by medically trained healthcare providers. It consists of a humidification chamber, heated wire breathing circuits (adult and neonate versions), and a dual sensor temperature probe to monitor humidification chamber output and airway proximal temperature. The device is supplied as a reusable system with specific models including RC70000, RC70072, RC70075, and RC70077.

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