Cleared Traditional

K945478 - AM-50 AEROSOL/MEDICATION AIR COMPRESSOR

K945478 is an FDA 510(k) clearance for AM-50 AEROSOL/MEDICATION AIR COMPRESSOR, manufactured by Preferred Medical Supply, Inc.. The device is a Class 2 Anesthesiology device with product code BTI cleared through the Traditional 510(k) pathway after a 324-day FDA review.

K945478 · Preferred Medical Supply, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
324d
Days
Class 2
Risk

K945478 is an FDA 510(k) clearance for the AM-50 AEROSOL/MEDICATION AIR COMPRESSOR. Classified as Compressor, Air, Portable (product code BTI), Class II - Special Controls.

Submitted by Preferred Medical Supply, Inc. (Buffalo, US). The FDA issued a Cleared decision on September 28, 1995 after a review of 324 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Preferred Medical Supply, Inc. devices

FDA 510(k) Submission Details - K945478

510(k) Number K945478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1994
Decision Date September 28, 1995
Days to Decision 324 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
184d slower than avg
Panel avg: 140d · This submission: 324d
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 42
Devices cleared under the same product code (BTI) and FDA review panel - the closest regulatory comparables to K945478.
SAN UP S.A. NEBULIZER COMPRESSOR, WITH DISPOSABLE NEBULIZER, MODEL 3050
K002468 · San UP S.A. · Mar 2001
MEDICAL AIR COMPRESSOR, MODEL # 8413419
K982789 · Drager, Inc. · Oct 1998
DEVILBISS 8650D
K963349 · Devilbiss Health Care, Inc. · Jun 1997
503 MAXI COMPRESSOR
K940630 · Medical Industries America, Inc. · Feb 1995
PM PUMP COMPRESSOR
K930509 · Precision Medical, Inc. · Oct 1994
DEVILBISS MODEL 4650 COMPRESSOR NEUBULIZER
K931015 · Devilbiss Health Care, Inc. · Sep 1993