Cleared Traditional

K923946 - CONCHATHERM IV HEATED MOLECULAR HUMIDIFIER

K923946 is an FDA 510(k) clearance for CONCHATHERM IV HEATED MOLECULAR HUMIDIFIER, manufactured by Hudson Respiratory Care, Inc.. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 804-day FDA review.

K923946 · Hudson Respiratory Care, Inc. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Oct 1994
Decision
804d
Days
Class 2
Risk

K923946 is an FDA 510(k) clearance for the CONCHATHERM IV HEATED MOLECULAR HUMIDIFIER. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Hudson Respiratory Care, Inc. (Temecula, US). The FDA issued a Cleared decision on October 18, 1994 after a review of 804 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Hudson Respiratory Care, Inc. devices

FDA 510(k) Submission Details - K923946

510(k) Number K923946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1992
Decision Date October 18, 1994
Days to Decision 804 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
664d slower than avg
Panel avg: 140d · This submission: 804d
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 134
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K923946.
HUMIDIFIER ADAPTER
K962079 · Automatic Liquid Packaging, Inc. · Jul 1996
HC500 SERVO-CONTROLLED HEATED RESPIRATORY HUMIDIFIER (& ACCESSORIES)
K953392 · Fisher & Paykel Electronics , Ltd. · Mar 1996
HUMIDIFIER
K945782 · Respironics, Inc. · Mar 1996
PURITAN-BENNETT CASCADE I SERIES HUMIDIFIER MODIFICATION
K936000 · Puritan Bennett Corp. · Aug 1994
MR290 HUMIDIFICATION CHAMBER SINGLE USE
K934140 · Fisher & Paykel Electronics , Ltd. · Jan 1994
HEATED RESPIRATORY HUMIDIFIER HC100
K915460 · Fisher & Paykel Electronics , Ltd. · Jan 1993