Cleared Traditional

K071958 - THERA-HEAT HEATED HUMIDIFIER AND ADULT DUAL AND SINGLE LIMB HEATED WIRE VENTILATOR BREATHING CIRCUITS

K071958 is an FDA 510(k) clearance for THERA-HEAT HEATED HUMIDIFIER AND ADULT ..., manufactured by Smiths Medical Asd, Inc.. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K071958 · Smiths Medical Asd, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
128d
Days
Class 2
Risk

K071958 is an FDA 510(k) clearance for the THERA-HEAT HEATED HUMIDIFIER AND ADULT DUAL AND SINGLE LIMB HEATED WIRE VENT.... Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Smiths Medical Asd, Inc. (Rockland, US). The FDA issued a Cleared decision on November 21, 2007 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5450 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K071958

510(k) Number K071958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2007
Decision Date November 21, 2007
Days to Decision 128 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 140d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTT Device Classification - Class 2, Special Controls

Product Code BTT Humidifier, Respiratory Gas, (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5450
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BTT Humidifier, Respiratory Gas, (direct Patient Interface)

All 179
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K071958.
HUMIDAIRE 2I
K080797 · Resmed, Ltd. · Jul 2008
RESPIRATORY HUMIDIFIER, MODEL MR850
K073706 · Fisher &Paykel Healthcare , Ltd. · Mar 2008
PARI HYDRATE V
K072982 · Pari Innovative Manufacturers, Inc. · Nov 2007
MEDISIZE GOLD HEATER AND BOOSTER
K070714 · Medisize BV · Apr 2007
CHONCHA THERM NEPTUNE HEATED HUMIFIER, CHONCHA THERM NEPTUNE HEATED HUMIFIER (REMANUFACTURER), MODEL# 425-00,425-00R
K063758 · Teleflex Medical · Apr 2007
VAPOTHERM MODEL# 2000I AND 2000H
K070056 · Vapotherm, Inc. · Apr 2007