Cleared Traditional

K883132 - NEBULIZER PUMP POWERED MODELS 020 AND 050

K883132 is an FDA 510(k) clearance for NEBULIZER PUMP POWERED MODELS 020 AND 050, manufactured by Travelneb, Inc.. The device is a Class 2 Anesthesiology device with product code BTI cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K883132 · Travelneb, Inc. · Anesthesiology device
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Oct 1988
Decision
84d
Days
Class 2
Risk

K883132 is an FDA 510(k) clearance for the NEBULIZER PUMP POWERED MODELS 020 AND 050. Classified as Compressor, Air, Portable (product code BTI), Class II - Special Controls.

Submitted by Travelneb, Inc. (Englewood, US). The FDA issued a Cleared decision on October 18, 1988 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K883132

510(k) Number K883132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1988
Decision Date October 18, 1988
Days to Decision 84 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 140d · This submission: 84d
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 52
Devices cleared under the same product code (BTI) and FDA review panel - the closest regulatory comparables to K883132.
PM14 SOFT AIR COMPRESSOR
K902762 · Precision Medical, Inc. · Jul 1990
MAXI COMPRESSORS
K900686 · Medical Industries America, Inc. · Apr 1990
PORTABLE AIR COMPRESSOR MODEL NUMBER 8125
K894831 · Equi-Tron Mfg., Inc. · Oct 1989
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
K883132 · NEBULIZER PUMP POWERED MODELS 020 AND 050
Download PDF Travelneb, Inc.