Cleared Traditional

K962079 - HUMIDIFIER ADAPTER

K962079 is an FDA 510(k) clearance for HUMIDIFIER ADAPTER, manufactured by Automatic Liquid Packaging, Inc.. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K962079 · Automatic Liquid Packaging, Inc. · Anesthesiology device
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Jul 1996
Decision
64d
Days
Class 2
Risk

K962079 is an FDA 510(k) clearance for the HUMIDIFIER ADAPTER. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Automatic Liquid Packaging, Inc. (Woodstock, US). The FDA issued a Cleared decision on July 31, 1996 after a review of 64 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 Automatic Liquid Packaging, Inc. devices

FDA 510(k) Submission Details - K962079

510(k) Number K962079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1996
Decision Date July 31, 1996
Days to Decision 64 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 140d · This submission: 64d
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 123
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K962079.
OASIS HUMIDIFIER
K964653 · Respironics, Inc. · Feb 1997
WATER CHAMBERS FOR ST 3000 HEATED HUMIDIFIER
K962223 · Marquest Medical Products, Inc. · Jan 1997
SLEEPNET HUMIDIFIER,(84200 PACKAGED)
K963025 · Sleepnet Corporation · Nov 1996
HUMIDIFIER
K945782 · Respironics, Inc. · Mar 1996
PURITAN-BENNETT CASCADE I SERIES HUMIDIFIER MODIFICATION
K936000 · Puritan Bennett Corp. · Aug 1994
OPTI-MOL FILTERED PUNCTURE PIN
K920306 · Automatic Liquid Packaging, Inc. · Apr 1992