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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 73
Devices cleared under the same product code (BTI) and FDA review panel - the closest regulatory comparables to K946039.
ALRECO 40400
K951926 · Allan Rehnstrom AB · Dec 1995
AM-50 AEROSOL/MEDICATION AIR COMPRESSOR
K945478 · Preferred Medical Supply, Inc. · Sep 1995
MICROTIME
K952616 · Westmed Intl. · Sep 1995
503 MAXI COMPRESSOR
K940630 · Medical Industries America, Inc. · Feb 1995
PM PUMP COMPRESSOR
K930509 · Precision Medical, Inc. · Oct 1994
NEBULIZER PUMP, POWERED, MODEL 1110
K925010 · Thomas Industries · May 1994
K946039 · MODEL #5000 PULMO PLUS
Download PDF FDA Summary International Medical…