FDA Product Code LQK: Home Uterine Activity Monitor
Leading manufacturers include Nuvo- Group , Ltd., Huntleigh Diagnostics , Ltd. and Airstrip Technologies, Inc..
6
Total
6
Cleared
162d
Avg days
2002
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
Review times increasing: avg
286d
recently vs 137d historically
FDA 510(k) Cleared Home Uterine Activity Monitor Devices (Product Code LQK)
6 devices
Cleared
Sep 03, 2026
M•care System (MW-20)
Marani Health, Inc.
Obstetrics & Gynecology
286d
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
Cleared
Mar 27, 2020
PregSense
Nuvo- Group , Ltd.
Obstetrics & Gynecology
308d
Cleared
Mar 10, 2015
Sense4Baby System Model B+ (MSA)
Airstrip Technologies, Inc.
Obstetrics & Gynecology
131d
Cleared
Apr 19, 2002
MODIFICATION TO FETAL ASSIST
Huntleigh Diagnostics , Ltd.
Obstetrics & Gynecology
72d
About Product Code LQK - Regulatory Context
510(k) Submission Activity
6 total 510(k) submissions under product code LQK since 2002, with 6 receiving FDA clearance (average review time: 162 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - LQK Product Code
Recent submissions under LQK have taken an average of 286 days to reach a decision - up from 137 days historically. Manufacturers should account for longer review timelines in current project planning.
LQK devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →