FDA Product Code JXL: Block, Bite
Leading manufacturers include Mecta Corporation and Neurovice, LLC.
28
Total
28
Cleared
100d
Avg days
1976
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Block, Bite Devices (Product Code JXL)
28 devices
Cleared
Feb 22, 2023
PATI (Protector Against Tongue Injury)
Neurovice, LLC
Neurology
278d
Cleared
Jun 04, 2021
ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium
Mecta Corporation
Neurology
385d
About Product Code JXL - Regulatory Context
510(k) Submission Activity
28 total 510(k) submissions under product code JXL since 1976, with 28 receiving FDA clearance (average review time: 100 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
JXL devices are reviewed by the Neurology panel. Browse all Neurology devices →