Cleared Traditional

K033028 - ANEFIN

K033028 is an FDA 510(k) clearance for ANEFIN, manufactured by Axon Medical. The device is a Class 2 Anesthesiology device with product code CBN cleared through the Traditional 510(k) pathway after a 665-day FDA review.

K033028 · Axon Medical · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Axon Medical devices

FDA 510(k) Submission Details - K033028

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
525d slower than avg
Panel avg: 140d · This submission: 665d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBN Device Classification - Class 2, Special Controls

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.

Regulatory Peers - CBN Apparatus, Gas-scavenging

All 14
Devices cleared under the same product code (CBN) and FDA review panel - the closest regulatory comparables to K033028.
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