Cleared Traditional

K883704 - MULTIICHALLENGE NEBULIZER SYSTEM

K883704 is an FDA 510(k) clearance for MULTIICHALLENGE NEBULIZER SYSTEM, manufactured by Biotrine Corp.. The device is a Class 2 Anesthesiology device with product code BTI cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K883704 · Biotrine Corp. · Anesthesiology device
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Nov 1988
Decision
90d
Days
Class 2
Risk

K883704 is an FDA 510(k) clearance for the MULTIICHALLENGE NEBULIZER SYSTEM. Classified as Compressor, Air, Portable (product code BTI), Class II - Special Controls.

Submitted by Biotrine Corp. (Woburn, US). The FDA issued a Cleared decision on November 28, 1988 after a review of 90 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K883704

510(k) Number K883704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1988
Decision Date November 28, 1988
Days to Decision 90 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 140d · This submission: 90d
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 46
Devices cleared under the same product code (BTI) and FDA review panel - the closest regulatory comparables to K883704.
#504 MINI COMPRESSOR
K904045 · Medical Industries America, Inc. · Feb 1991
PM14 SOFT AIR COMPRESSOR
K902762 · Precision Medical, Inc. · Jul 1990
MAXI COMPRESSORS
K900686 · Medical Industries America, Inc. · Apr 1990
ECONO-MIST PORTABLE COMPRESSOR DRIVEN NEBULIZER
K873677 · Mountain Medical Equipment, Inc. · Oct 1987
SIEMENS DRY AIR COMPRESSOR
K871829 · Siemens Elema AB · Jun 1987
BIRD 6500 AIR COMPRESSOR
K864547 · Bird Products Corp. · Jan 1987