Cleared Traditional

K130937 - WAVE 2G, SOUL

K130937 is an FDA 510(k) clearance for WAVE 2G, manufactured by Hansaton Akustik GmbH. The device is a Class 2 Ear, Nose, Throat device with product code KLW cleared through the Traditional 510(k) pathway after a 274-day FDA review.

K130937 · Hansaton Akustik GmbH · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Jan 2014
Decision
274d
Days
Class 2
Risk

K130937 is an FDA 510(k) clearance for the WAVE 2G, SOUL. Classified as Masker, Tinnitus (product code KLW), Class II - Special Controls.

Submitted by Hansaton Akustik GmbH (Hamburg, DE). The FDA issued a Cleared decision on January 3, 2014 after a review of 274 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3400 - 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 Hansaton Akustik GmbH devices

FDA 510(k) Submission Details - K130937

510(k) Number K130937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2013
Decision Date January 03, 2014
Days to Decision 274 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
184d slower than avg
Panel avg: 90d · This submission: 274d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLW Device Classification - Class 2, Special Controls

Product Code KLW Masker, Tinnitus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3400
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 - KLW Masker, Tinnitus

All 60
Devices cleared under the same product code (KLW) and FDA review panel - the closest regulatory comparables to K130937.
LEVO TINNITUS MASKING SOFTWARE DEVICE
K140845 · Otoharmonics Corp · Jul 2014
SOLACE SOUND GENERATORS
K132965 · Amplisound Hearing Products & Services · Mar 2014
TINNITUS SOUNDSUPPORT
K133308 · Oticon A/S · Mar 2014
AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRT
K130514 · Audifon-USA, Inc. · Nov 2013
AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S
K130417 · Audifon-USA, Inc. · Sep 2013
UNITRON TINNITUS MASKER FEATURE
K130494 · Unitron Hearing · May 2013