Cleared Traditional

K962223 - WATER CHAMBERS FOR ST 3000 HEATED HUMIDIFIER

K962223 is an FDA 510(k) clearance for WATER CHAMBERS FOR ST 3000 HEATED HUMID..., manufactured by Marquest Medical Products, Inc.. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K962223 · Marquest Medical Products, Inc. · Anesthesiology device
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Jan 1997
Decision
218d
Days
Class 2
Risk

K962223 is an FDA 510(k) clearance for the WATER CHAMBERS FOR ST 3000 HEATED HUMIDIFIER. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Marquest Medical Products, Inc. (Englewood, US). The FDA issued a Cleared decision on January 14, 1997 after a review of 218 days - an extended review cycle.

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.

View all Marquest Medical Products, Inc. devices

FDA 510(k) Submission Details - K962223

510(k) Number K962223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1996
Decision Date January 14, 1997
Days to Decision 218 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
78d slower than avg
Panel avg: 140d · This submission: 218d
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 162
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K962223.
SULLIVAN HUMIDAIRE HEATED HUMIDIFIER
K971260 · ResMed Corp · Sep 1997
SCT 3000 HEATED HUMIDIFIER
K970478 · Marquest Medical Products, Inc. · Jul 1997
OASIS HUMIDIFIER
K964653 · Respironics, Inc. · Feb 1997
SLEEPNET HUMIDIFIER,(84200 PACKAGED)
K963025 · Sleepnet Corporation · Nov 1996
HUMIDIFIER ADAPTER
K962079 · Automatic Liquid Packaging, Inc. · Jul 1996
HC500 SERVO-CONTROLLED HEATED RESPIRATORY HUMIDIFIER (& ACCESSORIES)
K953392 · Fisher & Paykel Electronics , Ltd. · Mar 1996