Cleared Traditional

K946039 - MODEL #5000 PULMO PLUS

K946039 is an FDA 510(k) clearance for MODEL #5000 PULMO PLUS, manufactured by International Medical Systems. The device is a Class 2 Anesthesiology device with product code BTI cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K946039 · International Medical Systems · Anesthesiology device
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Jun 1995
Decision
186d
Days
Class 2
Risk

K946039 is an FDA 510(k) clearance for the MODEL #5000 PULMO PLUS. Classified as Compressor, Air, Portable (product code BTI), Class II - Special Controls.

Submitted by International Medical Systems (West Des Molnes, US). The FDA issued a Cleared decision on June 16, 1995 after a review of 186 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 International Medical Systems devices

FDA 510(k) Submission Details - K946039

510(k) Number K946039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1994
Decision Date June 16, 1995
Days to Decision 186 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 140d · This submission: 186d
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 35
Devices cleared under the same product code (BTI) and FDA review panel - the closest regulatory comparables to K946039.
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K931015 · Devilbiss Health Care, Inc. · Sep 1993