Cleared Traditional

K023354 - COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
Regulatory Context
Review time vs. panel average
194d slower than avg
Panel avg: 139d · This submission: 333d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.