Cleared Traditional

DDAT OMT (K050098) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K050098 · Ddat(Uk), Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
125d
Days
Class 2
Risk

K050098 is an FDA 510(k) clearance for the DDAT OMT. Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by Ddat(Uk), Ltd. (Basingstoke, Hampshire, GB). The FDA issued a Cleared decision on May 23, 2005 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1460 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ddat(Uk), Ltd. devices

Submission Details

510(k) Number K050098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2005
Decision Date May 23, 2005
Days to Decision 125 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 148d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code GWN Nystagmograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1460
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 - GWN Nystagmograph

All 58
Devices cleared under the same product code (GWN) and FDA review panel - the closest regulatory comparables to K050098.
NeuroEars-Anna™
K243709 · Neuroears, Inc. · Aug 2025
ICS Dizcovery (1091)
K242198 · Natus Medical Denmark Aps · Feb 2025
Synapsys VHIT
K242726 · Inventis S.R.L. · Jan 2025
NeuroSwift Pro
K223047 · Neurobit Technologies Co., Ltd. · Jun 2023
Insight Infrared Video Goggles
K203082 · Vestibular First · Nov 2020
VisualEyes
K200534 · Interacoustics A/S · Aug 2020