Cleared Traditional

K970478 - SCT 3000 HEATED HUMIDIFIER

K970478 is an FDA 510(k) clearance for SCT 3000 HEATED HUMIDIFIER, 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 159-day FDA review.

K970478 · Marquest Medical Products, Inc. · Anesthesiology device
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Jul 1997
Decision
159d
Days
Class 2
Risk

K970478 is an FDA 510(k) clearance for the SCT 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 July 16, 1997 after a review of 159 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 - K970478

510(k) Number K970478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1997
Decision Date July 16, 1997
Days to Decision 159 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
19d slower than avg
Panel avg: 140d · This submission: 159d
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 98
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K970478.
CLOUD 1 HUMIDIFICATION SYSTEM
K983862 · Respiratory Support Products, Inc. · May 1999
AIRLIFE BUBBLE HUMIDIFER, MODEL 002003 AND 002006
K991484 · Allegiance Healthcare Corp. · May 1999
RESPIRATORY HUMIDIFIER, MODEL # MR850
K983112 · Fisher &Paykel Healthcare , Ltd. · Nov 1998
OASIS HUMIDIFIER
K964653 · Respironics, Inc. · Feb 1997
WATER CHAMBERS FOR ST 3000 HEATED HUMIDIFIER
K962223 · Marquest Medical Products, Inc. · Jan 1997
HUMIDIFIER
K945782 · Respironics, Inc. · Mar 1996