Cleared Traditional

K050098 - DDAT OMT

K050098 is an FDA 510(k) clearance for DDAT OMT, manufactured by Ddat(Uk), Ltd.. The device is a Class 2 Neurology device with product code GWN cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K050098 · Ddat(Uk), Ltd. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K050098

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 149d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

GWN Device Classification - Class 2, Special Controls

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 Consultant

Underwriters Laboratories, Inc.
CHANTEL CARSON

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 - GWN Nystagmograph

All 59
Devices cleared under the same product code (GWN) and FDA review panel - the closest regulatory comparables to K050098.
BALANCEBACK MOBILE INTUITIVE VNG SYSTEM
K070729 · Fall Prevention Technologies, LLC · Mar 2007
CHRONOS VISION EYE TRACKING DEVICE (C-ETD)
K062015 · Chronos Vision · Oct 2006
FOCUS VNG/ENG TYPE 1068
K061791 · Gn Otometrics A/S · Jul 2006
BALANCEBACK VNG SYSTEM
K042529 · Fall Prevention Technologies, LLC · Oct 2004
ICS MEDICAL MODEL VG-30 VIDEO GOGGLES
K013060 · Ics Medical · Dec 2001
ENGPLUS
K010059 · Western Systems Research, Inc. · Feb 2001
K050098 · DDAT OMT
Download PDF FDA Summary Ddat(Uk), Ltd.