Cleared Traditional

K894000 - THERA-MIST HUMIDIFIER

K894000 is an FDA 510(k) clearance for THERA-MIST HUMIDIFIER, manufactured by Pegasus Research Corp.. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K894000 · Pegasus Research Corp. · Anesthesiology device
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Aug 1989
Decision
84d
Days
Class 2
Risk

K894000 is an FDA 510(k) clearance for the THERA-MIST HUMIDIFIER. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Pegasus Research Corp. (Costa Mesa, US). The FDA issued a Cleared decision on August 28, 1989 after a review of 84 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 Pegasus Research Corp. devices

FDA 510(k) Submission Details - K894000

510(k) Number K894000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1989
Decision Date August 28, 1989
Days to Decision 84 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 140d · This submission: 84d
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 124
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K894000.
DEVILBISS AP-50 COMPRESSOR/NEBULIZER
K900602 · Devilbiss Health Care, Inc. · Apr 1990
JOHN BUNN: MEDIX COMPACT TRAVELLER
K900854 · The John Bunn Co. · Apr 1990
BEAR VH820 DISPOSABLE CHAMBER ASSEMBLY
K896315 · Bear Medical Systems, Inc. · Jan 1990
VHS 820 HUMIDIFIER, MODIFICATION
K893034 · Bear Medical Systems, Inc. · Jul 1989
MODEL MR2000 HEATED RESPIRATORY HUMIDIFIER
K881970 · Fisher &Paykel Healthcare , Ltd. · Mar 1989
MODIFIED CONCHATHERM III CONTROLLED HEATER
K884150 · Respiratory Care, Inc. · Nov 1988