LXV

FDA Product Code LXV: Apparatus, Vestibular Analysis

Leading manufacturers include Interacoustics A/S, Ultrathera Technologies, Inc. and King-Devick Technologies, Inc..

22
Total
22
Cleared
154d
Avg days
1977
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Apparatus, Vestibular Analysis Devices (Product Code LXV)

22 devices
1–22 of 22
Cleared Apr 27, 2022
GyroStim
K220231
Ultrathera Technologies, Inc.
Ear, Nose, Throat · 90d
Cleared Aug 12, 2020
Orion
K200529
Interacoustics A/S
Ear, Nose, Throat · 163d
Cleared May 27, 2020
TRV
K192652
Interacoustics A/S
Ear, Nose, Throat · 246d
Cleared Oct 22, 2019
ClearEdge Balance System
K183661
Quadrant Biosciences
Ear, Nose, Throat · 299d
Cleared Aug 16, 2019
EQ Balance
K190735
Upright Science, Inc.
Ear, Nose, Throat · 148d
Cleared Apr 02, 2018
K-D Balance
K173669
King-Devick Technologies, Inc.
Ear, Nose, Throat · 123d

About Product Code LXV - Regulatory Context

510(k) Submission Activity

22 total 510(k) submissions under product code LXV since 1977, with 22 receiving FDA clearance (average review time: 154 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.