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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

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
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 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 K020900.
INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000
K031176 · Invacare Corp. · Mar 2004
RESPIRATORY HUMIDIFIER, MODEL MR850
K020332 · Fisher &Paykel Healthcare , Ltd. · Jul 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
INVACARE PASSOVER HUMIDIFIER MODEL ISP9700
K003561 · Invacare Corp. · Apr 2001