Cleared Traditional

K113831 - PRIMUS HEARING INSTRUMENT TEST UNIT

K113831 is an FDA 510(k) clearance for PRIMUS HEARING INSTRUMENT TEST UNIT, manufactured by Auditdata A/S. The device is a Class 2 Ear, Nose, Throat device with product code ETW cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K113831 · Auditdata A/S · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Apr 2012
Decision
114d
Days
Class 2
Risk

K113831 is an FDA 510(k) clearance for the PRIMUS HEARING INSTRUMENT TEST UNIT. Classified as Calibrator, Hearing Aid / Earphone And Analysis Systems (product code ETW), Class II - Special Controls.

Submitted by Auditdata A/S (Taastrup, DK). The FDA issued a Cleared decision on April 19, 2012 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3310 - 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 Auditdata A/S devices

FDA 510(k) Submission Details - K113831

510(k) Number K113831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2011
Decision Date April 19, 2012
Days to Decision 114 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 89d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ETW Device Classification - Class 2, Special Controls

Product Code ETW Calibrator, Hearing Aid / Earphone And Analysis Systems
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3310
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 - ETW Calibrator, Hearing Aid / Earphone And Analysis Systems

All 10
Devices cleared under the same product code (ETW) and FDA review panel - the closest regulatory comparables to K113831.
UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)
K071462 · Siemens Hearing Instruments, Inc. · Jun 2007
RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM
K960229 · Resound Corp. · Mar 1996
SIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110/SD WITH UNITY SOPFTWARE SUITE
K952098 · Siemens Hearing Instruments, Inc. · May 1995
DESKREM-1000
K943459 · Starkey Laboratories, Inc. · Oct 1994
PORTAREM 2000
K943460 · Starkey Laboratories, Inc. · Oct 1994
AUDIOMETER
K870337 · Bio-Logic Systems Corp. · Apr 1987