Cleared Traditional

K003626 - DEVILBISS HUMIDIFIER

K003626 is an FDA 510(k) clearance for DEVILBISS HUMIDIFIER, manufactured by Sunrise Medical Hhg, Inc.. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K003626 · Sunrise Medical Hhg, Inc. · Anesthesiology device
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May 2001
Decision
161d
Days
Class 2
Risk

K003626 is an FDA 510(k) clearance for the DEVILBISS HUMIDIFIER. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Sunrise Medical Hhg, Inc. (Somerset, US). The FDA issued a Cleared decision on May 4, 2001 after a review of 161 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 Sunrise Medical Hhg, Inc. devices

FDA 510(k) Submission Details - K003626

510(k) Number K003626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2000
Decision Date May 04, 2001
Days to Decision 161 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
21d slower than avg
Panel avg: 140d · This submission: 161d
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 K003626.
H2 HEATED HUMIDIFIER
K030090 · Respironics, Inc. · Jan 2003
RESPIRONICS HEATED HUMIDIFIER
K012633 · Respironics, Inc. · Feb 2002
RESPIRATORY HUMIDIFIER, MODEL HC150
K003973 · Fisher &Paykel Healthcare , Ltd. · Jun 2001
INVACARE PASSOVER HUMIDIFIER MODEL ISP9700
K003561 · Invacare Corp. · Apr 2001
BREAS HA50 HUMIDIFIER, MODEL HA50
K002454 · Vital Signs, Inc. · Mar 2001
HEATED HUMIDIFIER
K983783 · Pegasus Research Corp. · Oct 2000