Cleared Traditional

K770415 - HUMIDIFIER

K770415 is the FDA 510(k) clearance for HUMIDIFIER by M.G. Humidifiers, Inc.. It is a Class 2 Anesthesiology device (product code BTT) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K770415 · M.G. Humidifiers, Inc. · Anesthesiology device
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Apr 1977
Decision
34d
Days
Class 2
Risk

K770415 is an FDA 510(k) clearance for the HUMIDIFIER, DISPOSABLE. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by M.G. Humidifiers, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 7, 1977 after a review of 34 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 M.G. Humidifiers, Inc. devices

Submission Details

510(k) Number K770415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1977
Decision Date April 07, 1977
Days to Decision 34 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 140d · This submission: 34d
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 K770415.
RESPIRATORY THERAPY SOLUTIONS - FLEXIBLE
K780381 · Travenol Laboratories, S.A. · May 1978
RESPIRATORY THERAPY SOLUTIONS - FLEXIBLE
K780385 · Travenol Laboratories, S.A. · May 1978
HYMIDIFIER
K780088 · 3M Company · Feb 1978
VENTILATOR SET - CODE 2C7109
K770249 · Travenol Laboratories, S.A. · Feb 1977
HUMIDIFIER-CASCADE II
K760923 · Puritan Bennett Corp. · Nov 1976
DISPOSABLE HUMIDIFIER
K760938 · Travenol Laboratories, S.A. · Nov 1976