Cleared Traditional

K182214 - DizzyDoctor System 1.0.0 (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K182214 · Dizzydoctor Systems, LLC · Ear, Nose, Throat device
Sep 2018
Decision
30d
Days
Class 2
Risk

K182214 is an FDA 510(k) clearance for the DizzyDoctor System 1.0.0. Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by Dizzydoctor Systems, LLC (San Diego, US). The FDA issued a Cleared decision on September 14, 2018 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 882.1460 - 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.

Submission Details

510(k) Number K182214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2018
Decision Date September 14, 2018
Days to Decision 30 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
128d faster than avg
Panel avg: 158d · This submission: 30d
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 Ear, Nose, Throat devices follow this clearance model.