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Humid-Heat

by Hudson Rcj AB

510(k) K993773

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 NumberK993773 Date13 Sep 2000ClearedStatusActive

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  • Withdrawn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, 26 Sep 2026

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

Humid-Heat is a respiratory gas humidifier with direct patient interface, classified as a Class 2 device in the Anesthesiology specialty. It is substantially equivalent to a predicate device and received FDA 510(k) clearance under product code BTT and regulation number 868.5450.

The device was manufactured by Hudson Rcj AB, with the 510(k) submission received on November 8, 1999, and cleared on September 13, 2000, via the Traditional pathway. It is identified by the K-number K993773 and is intended for use in anesthesiology settings as a respiratory gas humidifier.

Questions

AI-generated answers, 26 Sep 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 HUMID-HEAT device used for?

    The HUMID-HEAT is a respiratory gas humidifier with direct patient interface intended for use in anesthesiology settings to condition inhaled gases by adding heat and moisture, based on its FDA 510(k) clearance as substantially equivalent to a predicate device.

  • Is the HUMID-HEAT a single-use or reusable device?

    The provided device data does not specify whether the HUMID-HEAT is single-use or reusable; therefore, no determination can be made about its reusability from the available information.

  • What regulatory pathway was used for the HUMID-HEAT device?

    The HUMID-HEAT received FDA 510(k) clearance through the Traditional pathway, with submission date November 8, 1999, and clearance date September 13, 2000, under K-number K993773.