Cleared Traditional

K822335 - AUDIT

K822335 is an FDA 510(k) clearance for AUDIT, manufactured by Axonics, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K822335 · Axonics, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1983
Decision
187d
Days
Class 2
Risk

K822335 is an FDA 510(k) clearance for the AUDIT. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Axonics, Inc. (Walker, US). The FDA issued a Cleared decision on February 7, 1983 after a review of 187 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1050 - the FDA ear, nose and throat 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Axonics, Inc. devices

FDA 510(k) Submission Details - K822335

510(k) Number K822335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1982
Decision Date February 07, 1983
Days to Decision 187 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 90d · This submission: 187d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EWO Device Classification - Class 2, Special Controls

Product Code EWO Audiometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1050
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - EWO Audiometer

All 131
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K822335.
MA25 PORTABLE AUDIOMETER
K853919 · Maico Hearing Instruments, Inc. · Dec 1985
UP800 A UNIVERSAL PRINTER
K845050 · Madsen Electronics (Canada) , Ltd. · May 1985
AUDIOMETER MA728
K841567 · Maico Hearing Instruments, Inc. · Jun 1984
THE SCREENING TYMPANOMETER
K822745 · American Electromedics Corp. · Sep 1982
PORTABLE AUDIOMETERS
K811727 · Maico Hearing Instruments, Inc. · Jul 1981
TINNITUS RESEARCH AUDIOMETER
K802560 · Starkey Laboratories, Inc. · Nov 1980