FDA Product Code LQK: Home Uterine Activity Monitor
Leading manufacturers include Nuvo- Group , Ltd..
5
Total
5
Cleared
137d
Avg days
2002
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Home Uterine Activity Monitor Devices (Product Code LQK)
5 devices
Cleared
May 06, 2022
Invu by Nuvo
Nuvo- Group , Ltd.
Obstetrics & Gynecology
28d
Cleared
May 28, 2021
INVU by Nuvo
Nuvo- Group , Ltd.
Obstetrics & Gynecology
144d
About Product Code LQK - Regulatory Context
510(k) Submission Activity
5 total 510(k) submissions under product code LQK since 2002, with 5 receiving FDA clearance (average review time: 137 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.
LQK devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →