Cleared Traditional

DEVILBISS MODEL 9200D HEATED HUMIDIFIER SYSTEM (K020900) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K020900 · Sunrise Medical Hhg, Inc. · Anesthesiology device
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Jun 2002
Decision
75d
Days
Class 2
Risk

K020900 is an FDA 510(k) clearance for the DEVILBISS MODEL 9200D HEATED HUMIDIFIER SYSTEM. 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 June 3, 2002 after a review of 75 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 Sunrise Medical Hhg, Inc. devices

Submission Details

510(k) Number K020900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2002
Decision Date June 03, 2002
Days to Decision 75 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 140d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 51
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K020900.
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K162553 · Fisher & Paykel Healthcare · Dec 2018
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K180474 · Tni Medical AG · Oct 2018
H2 HEATED HUMIDIFIER
K030090 · Respironics, Inc. · Jan 2003
RESPIRONICS HEATED HUMIDIFIER
K012633 · Respironics, Inc. · Feb 2002
OASIS HUMIDIFIER
K964653 · Respironics, Inc. · Feb 1997
HUMIDIFIER
K945782 · Respironics, Inc. · Mar 1996