Cleared Traditional

K033028 - ANEFIN, MODEL 100 (FDA 510(k) Clearance)

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

K033028 · Axon Medical · Anesthesiology device
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Jul 2005
Decision
665d
Days
Class 2
Risk

K033028 is an FDA 510(k) clearance for the ANEFIN, MODEL 100. Classified as Apparatus, Gas-scavenging (product code CBN), Class II - Special Controls.

Submitted by Axon Medical (Salt Lake City, US). The FDA issued a Cleared decision on July 22, 2005 after a review of 665 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5430 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

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Submission Details

510(k) Number K033028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2003
Decision Date July 22, 2005
Days to Decision 665 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
526d slower than avg
Panel avg: 139d · This submission: 665d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CBN Apparatus, Gas-scavenging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5430
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.