Cleared Traditional

K903138 - MARQUEST SCT 3000, HEATED HUMIDIFICATION SYSTEM

K903138 is an FDA 510(k) clearance for MARQUEST SCT 3000, 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 86-day FDA review.

K903138 · Marquest Medical Products, Inc. · Anesthesiology device
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Oct 1990
Decision
86d
Days
Class 2
Risk

K903138 is an FDA 510(k) clearance for the MARQUEST SCT 3000, HEATED HUMIDIFICATION SYSTEM. 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 October 11, 1990 after a review of 86 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Marquest Medical Products, Inc. devices

FDA 510(k) Submission Details - K903138

510(k) Number K903138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1990
Decision Date October 11, 1990
Days to Decision 86 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 140d · This submission: 86d
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 K903138.
OPTI-MOL FILTERED PUNCTURE PIN
K920306 · Automatic Liquid Packaging, Inc. · Apr 1992
MODELS MR700/MR720/MR730 DUAL SERVO RESP HUMID ACC
K913368 · Fisher & Paykel Electronics , Ltd. · Jan 1992
OPTIMOL RESPIRATORY HUMIDIFICATION SYSTEM
K911770 · Automatic Liquid Packaging, Inc. · Oct 1991
PRECISION MEDICAL DISPOSABLE HUMIDIFIER
K902970 · Precision Medical, Inc. · Aug 1990
PREFILLED FLEXIBLE R.T. CONTAINERS W/STER. SODIUM
K901762 · Automatic Liquid Packaging, Inc. · Jul 1990
DEVILBISS AP-50 COMPRESSOR/NEBULIZER
K900602 · Devilbiss Health Care, Inc. · Apr 1990