Cleared Traditional

K801619 - MIST2GEN TEMPTROL 10

K801619 is the FDA 510(k) clearance for MIST2GEN TEMPTROL 10 by Mistogen Equipment Co.. It is a Class 2 Anesthesiology device (product code BTT) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K801619 · Mistogen Equipment Co. · Anesthesiology device
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Aug 1980
Decision
20d
Days
Class 2
Risk

K801619 is an FDA 510(k) clearance for the MIST2GEN TEMPTROL 10. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Mistogen Equipment Co. (Mchenry, US). The FDA issued a Cleared decision on August 4, 1980 after a review of 20 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 Mistogen Equipment Co. devices

Submission Details

510(k) Number K801619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1980
Decision Date August 04, 1980
Days to Decision 20 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 140d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 76
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K801619.
HUMIDIFIER
K802852 · Airlife, Inc. · Feb 1981
2M8101 HEATED LIQUID LEVEL CONTROLLER
K802144 · Travenol Laboratories, S.A. · Sep 1980
2C 7140 HEATED HUMIDIFER CANNISTER
K802145 · Travenol Laboratories, S.A. · Sep 1980
NEBULIZER WITH AIR ENTERTAINER & ETC.
K801252 · Airlife, Inc. · Jun 1980
STERILE WATER & SALINE IN PLASTIC BTL.
K800753 · Travenol Laboratories, S.A. · Apr 1980
VENTILATOR SET
K800056 · Abbott Laboratories · Jan 1980