Cleared Traditional

K020900 - DEVILBISS MODEL 9200D HEATED HUMIDIFIER SYSTEM

K020900 is an FDA 510(k) clearance for DEVILBISS MODEL 9200D HEATED 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 75-day FDA review.

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.

FDA 510(k) Submission Details - K020900

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
Combination Product No
PCCP Authorized No
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.

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 Consultant

Entela, Inc.
N.E. DEVINE JR.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - BTT Humidifier, Respiratory Gas, (direct Patient Interface)

All 191
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K020900.
VAPOTHERM 2000H
K013486 · Vapotherm, Inc. · May 2003
PMH 1000 HEATED HUMIDIFIER
K013856 · Pegasus Research Corp. · Feb 2003
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
DEVILBISS HUMIDIFIER
K003626 · Sunrise Medical Hhg, Inc. · May 2001
K020900 · DEVILBISS MODEL 9200D HEATED HUMIDIFIER SYSTEM
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