Cleared Traditional

K081602 - DIZZYFIX

K081602 · Clearwater Clinical Limited · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
105d
Days
-
Risk

K081602 is an FDA 510(k) clearance for the DIZZYFIX. Classified as Apparatus, Vestibular Analysis (product code LXV).

Submitted by Clearwater Clinical Limited (Calgary, Alberta, CA). The FDA issued a Cleared decision on September 19, 2008 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel. 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 Clearwater Clinical Limited devices

FDA 510(k) Submission Details - K081602

510(k) Number K081602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2008
Decision Date September 19, 2008
Days to Decision 105 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 89d · This submission: 105d
Pathway characteristics
Predicate-based equivalence.

LXV Device Classification - Class 0,

Product Code LXV Apparatus, Vestibular Analysis
Device Class -