Cleared Traditional

K123795 - AXON-BUS PROSTHETIC SYSTEM

K123795 is an FDA 510(k) clearance for AXON-BUS PROSTHETIC SYSTEM, manufactured by Otto Bock Austria. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 540-day FDA review.

K123795 · Otto Bock Austria · Neurology device
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Jun 2014
Decision
540d
Days
Class 2
Risk

K123795 is an FDA 510(k) clearance for the AXON-BUS PROSTHETIC SYSTEM. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Otto Bock Austria (Vienna, AT). The FDA issued a Cleared decision on June 3, 2014 after a review of 540 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - the FDA neurology 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 Neurology submissions.

View all Otto Bock Austria devices

FDA 510(k) Submission Details - K123795

510(k) Number K123795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2012
Decision Date June 03, 2014
Days to Decision 540 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
392d slower than avg
Panel avg: 148d · This submission: 540d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXY Device Classification - Class 2, Special Controls

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 Neurology devices follow this clearance model.

Regulatory Peers - GXY Electrode, Cutaneous

All 221
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K123795.
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