Cleared Traditional

K023354 - COMPRESSOR MINI

K023354 is an FDA 510(k) clearance for COMPRESSOR MINI, manufactured by Siemens Elema AB. The device is a Class 2 Anesthesiology device with product code BTI cleared through the Traditional 510(k) pathway after a 333-day FDA review.

K023354 · Siemens Elema AB · Anesthesiology device
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Sep 2003
Decision
333d
Days
Class 2
Risk

K023354 is an FDA 510(k) clearance for the COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E. Classified as Compressor, Air, Portable (product code BTI), Class II - Special Controls.

Submitted by Siemens Elema AB (Danvers, US). The FDA issued a Cleared decision on September 5, 2003 after a review of 333 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 Siemens Elema AB devices

FDA 510(k) Submission Details - K023354

510(k) Number K023354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2002
Decision Date September 05, 2003
Days to Decision 333 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
193d slower than avg
Panel avg: 140d · This submission: 333d
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 19
Devices cleared under the same product code (BTI) and FDA review panel - the closest regulatory comparables to K023354.
MINIMATE COMPRESSOR
K051691 · Precision Medical, Inc. · Dec 2005
VENTILAIR II MEDICAL AIR COMPRESSOR
K041781 · Hamilton Medical AG · Mar 2005
AEROMIST LT, MODEL HCS15004
K031686 · Medline Industries, Inc. · Jan 2004
DEVILBISS 8650D
K963349 · Devilbiss Health Care, Inc. · Jun 1997
PM PUMP COMPRESSOR
K930509 · Precision Medical, Inc. · Oct 1994
DEVILBISS MODEL 4650 COMPRESSOR NEUBULIZER
K931015 · Devilbiss Health Care, Inc. · Sep 1993