Cleared Traditional

K922623 - NEBULIZER SYSTEM

K922623 is an FDA 510(k) clearance for NEBULIZER SYSTEM, manufactured by Healthdyne, Inc.. The device is a Class 2 Anesthesiology device with product code BTI cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K922623 · Healthdyne, Inc. · Anesthesiology device
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Dec 1992
Decision
182d
Days
Class 2
Risk

K922623 is an FDA 510(k) clearance for the NEBULIZER SYSTEM. Classified as Compressor, Air, Portable (product code BTI), Class II - Special Controls.

Submitted by Healthdyne, Inc. (Marietta, US). The FDA issued a Cleared decision on December 1, 1992 after a review of 182 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.6250 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Healthdyne, Inc. devices

FDA 510(k) Submission Details - K922623

510(k) Number K922623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1992
Decision Date December 01, 1992
Days to Decision 182 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
42d slower than avg
Panel avg: 140d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTI Device Classification - Class 2, Special Controls

Product Code BTI Compressor, Air, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.6250
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 - BTI Compressor, Air, Portable

All 30
Devices cleared under the same product code (BTI) and FDA review panel - the closest regulatory comparables to K922623.
PM PUMP COMPRESSOR
K930509 · Precision Medical, Inc. · Oct 1994
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SAM ST
K913097 · Ferguson Medical · Dec 1992
AIR STAR
K920954 · Infrasonics Corp. · Aug 1992
MAXI ASPIRATOR
K902184 · Medical Industries America, Inc. · Feb 1991
#504 MINI COMPRESSOR
K904045 · Medical Industries America, Inc. · Feb 1991