Cleared Traditional

K833974 - AQUAPAK 020 HUMIDIFIER ADAPTER

K833974 is an FDA 510(k) clearance for AQUAPAK 020 HUMIDIFIER ADAPTER, manufactured by Respiratory Care, Inc.. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K833974 · Respiratory Care, Inc. · Anesthesiology device
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Dec 1983
Decision
30d
Days
Class 2
Risk

K833974 is an FDA 510(k) clearance for the AQUAPAK 020 HUMIDIFIER ADAPTER. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Respiratory Care, Inc. (Walker, US). The FDA issued a Cleared decision on December 16, 1983 after a review of 30 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 Respiratory Care, Inc. devices

FDA 510(k) Submission Details - K833974

510(k) Number K833974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1983
Decision Date December 16, 1983
Days to Decision 30 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 140d · This submission: 30d
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 132
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K833974.
BIRD HEATED HUMIDIFIER 3201
K842523 · 3M Company · Jul 1984
NEBULO 28 NEBULIZER KIT
K841158 · Inspiron Corp. · Mar 1984
CONCHATHERM LHF HUMIDIFIER HEATER
K834151 · Respiratory Care, Inc. · Jan 1984
A QUAPAK
K811073 · Respiratory Care, Inc. · Apr 1981
NEBULIZER/HUMIDIFIER HUMIDITY CENTER-MI.
K810939 · Allied Healthcare Products, Inc. · Apr 1981
OPTI- SYSTEM
K810559 · Corpak Co. · Mar 1981