Cleared Traditional

K832220 - TRAVELER NEBULIZING SYSTEM

K832220 is an FDA 510(k) clearance for TRAVELER NEBULIZING SYSTEM, manufactured by Medix of Florida, Inc.. The device is a Class 2 Anesthesiology device with product code BTI cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K832220 · Medix of Florida, Inc. · Anesthesiology device
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Sep 1983
Decision
80d
Days
Class 2
Risk

K832220 is an FDA 510(k) clearance for the TRAVELER NEBULIZING SYSTEM. Classified as Compressor, Air, Portable (product code BTI), Class II - Special Controls.

Submitted by Medix of Florida, Inc. (Walker, US). The FDA issued a Cleared decision on September 26, 1983 after a review of 80 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 - K832220

510(k) Number K832220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1983
Decision Date September 26, 1983
Days to Decision 80 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 140d · This submission: 80d
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 K832220.
AIR COMPRESSOR
K850795 · Bear Medical Systems, Inc. · May 1985
IMPACT MODEL 601
K841537 · Impact Instrumentation, Inc. · May 1984
MEDI-MIST PORTA. COMPRESSOR DRIVEN
K833501 · Mountain Medical Equipment, Inc. · Dec 1983
PCS-5 ACCESSORIES
K812766 · Timeter Instrument Corp. · Dec 1981
SNIFF AIR COMPRESSOR #SF-6
K812767 · Timeter Instrument Corp. · Nov 1981
AIR COMPRESSOR ADAPTOR KIT
K802253 · Hudson Oxygen Therapy Sales Co. · Sep 1980
K832220 · TRAVELER NEBULIZING SYSTEM
Download PDF Medix of Florida, Inc.