Cleared Traditional

K833298 - AUDIT V AX 135

K833298 is an FDA 510(k) clearance for AUDIT V AX 135, manufactured by Axonics, Inc.. The device is a Class 2 Neurology device with product code GWK cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K833298 · Axonics, Inc. · Neurology device
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Dec 1983
Decision
69d
Days
Class 2
Risk

K833298 is an FDA 510(k) clearance for the AUDIT V AX 135. Classified as Conditioner, Signal, Physiological (product code GWK), Class II - Special Controls.

Submitted by Axonics, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 1, 1983 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1845 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Axonics, Inc. devices

FDA 510(k) Submission Details - K833298

510(k) Number K833298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1983
Decision Date December 01, 1983
Days to Decision 69 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 148d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWK Device Classification - Class 2, Special Controls

Product Code GWK Conditioner, Signal, Physiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1845
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 - GWK Conditioner, Signal, Physiological

All 13
Devices cleared under the same product code (GWK) and FDA review panel - the closest regulatory comparables to K833298.
BRAIN FUNCTION MAPPING OPTION FOR PATHF
K843598 · Nicolet Biomedical Instruments · Apr 1985
NEUROPACK 8 MEE 4108
K841497 · Nihon Kohden America, Inc. · Jun 1984
NEUROTRAC
K841110 · Interspec, Inc. · Apr 1984
EVOKED RESPONSE STIMULATORS
K803226 · Bio-Logic Systems Corp. · Feb 1981
PATHFINDER ELECTRODIAGNOSTIC SYSTEM
K801604 · Nicolet Biomedical Instruments · Aug 1980
AUDIO MONITOR-MODEL 8309
K780538 · Life-Tech Instruments, Inc. · Apr 1978