Cleared Traditional

K061104 - SPEECHLINK 100 TYPE 1053

K061104 is an FDA 510(k) clearance for SPEECHLINK 100 TYPE 1053, manufactured by Gn Otometrics 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 13-day FDA review.

K061104 · Gn Otometrics A/S · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
13d
Days
Class 2
Risk

K061104 is an FDA 510(k) clearance for the SPEECHLINK 100 TYPE 1053. Classified as Calibrator, Hearing Aid / Earphone And Analysis Systems (product code ETW), Class II - Special Controls.

Submitted by Gn Otometrics A/S (Taastrup, DK). The FDA issued a Cleared decision on May 3, 2006 after a review of 13 days - a notably fast clearance cycle.

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: 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 Gn Otometrics A/S devices

FDA 510(k) Submission Details - K061104

510(k) Number K061104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2006
Decision Date May 03, 2006
Days to Decision 13 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 90d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Intertek Testing Services
DANIEL W LEHTONEN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ETW Calibrator, Hearing Aid / Earphone And Analysis Systems

All 23
Devices cleared under the same product code (ETW) and FDA review panel - the closest regulatory comparables to K061104.
GN OTOMETRICS TYPE 1053 FREEFIT
K110286 · Gn Otometrics A/S · Apr 2011
FONIX ,MODEL 8000
K093006 · Frye Electronics, Inc. · Dec 2009
UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)
K071462 · Siemens Hearing Instruments, Inc. · Jun 2007
REM440
K050496 · Interacoustics A/S, Assens · Apr 2005
OTOGRAM
K041853 · Tympany, Inc. · Sep 2004
FONIX FP35 HEARING AID ANALYZER
K980377 · Frye Electronics, Inc. · Mar 1998

FDA 510(k) Resources - Ear, Nose, Throat

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.