Cleared Traditional

K220231 - GyroStim (FDA 510(k) Clearance)

K220231 · Ultrathera Technologies, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2022
Decision
90d
Days
-
Risk

K220231 is an FDA 510(k) clearance for the GyroStim. Classified as Apparatus, Vestibular Analysis (product code LXV).

Submitted by Ultrathera Technologies, Inc. (Colorado Springs, US). The FDA issued a Cleared decision on April 27, 2022 after a review of 90 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 Ultrathera Technologies, Inc. devices

Submission Details

510(k) Number K220231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2022
Decision Date April 27, 2022
Days to Decision 90 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 89d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LXV Apparatus, Vestibular Analysis
Device Class -