Cleared Traditional

K832072 - VITA-MIST AIR COMPRESSOR & NEBULIZER

K832072 is an FDA 510(k) clearance for VITA-MIST AIR COMPRESSOR & NEBULIZER, manufactured by Vita Medics. The device is a Class 2 Anesthesiology device with product code BTI cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K832072 · Vita Medics · Anesthesiology device

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Sep 1983

Decision

76d

Days

Class 2

Risk

K832072 is an FDA 510(k) clearance for the VITA-MIST AIR COMPRESSOR & NEBULIZER. Classified as Compressor, Air, Portable (product code BTI), Class II - Special Controls.

Submitted by Vita Medics (Mchenry, US). The FDA issued a Cleared decision on September 12, 1983 after a review of 76 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 - K832072

510(k) Number	K832072 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 28, 1983
Decision Date	September 12, 1983
Days to Decision	76 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

64d faster than avg

Panel avg: 140d · This submission: 76d

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 K832072.

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

FDA 510(k) Resources - Anesthesiology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K832072

Vita Medics

Mchenry, IL · US

Regulatory profile

1 submissions 1 cleared

100% clearance rate · Active in Anesthesiology

View all devices by Vita Medics →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: September 12, 1983. Record added to 510k Database: March 2026.

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