Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart C — Obstetrical and Gynecological Monitoring Devices](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices) → [21 CFR 884.2730](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/884.2730) → LQK — Home Uterine Activity Monitor

# LQK · Home Uterine Activity Monitor

_Obstetrics/Gynecology · 21 CFR 884.2730 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/LQK

## Overview

- **Product Code:** LQK
- **Device Name:** Home Uterine Activity Monitor
- **Regulation:** [21 CFR 884.2730](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/884.2730)
- **Device Class:** 2
- **Review Panel:** [Obstetrics/Gynecology](/submissions/OB)

## Identification

A home uterine activity monitor (HUAM) is an electronic system for at home antepartum measurement of uterine contractions. The HUAM system comprises a tocotransducer and an at-home recorder. This device is intended for use in women with a previous preterm delivery to aid in the detection of preterm labor.

## Classification Rationale

Class II (special controls); guidance document (Class II Special Controls Guidance for Home Uterine Activity Monitors).

## Special Controls

*Classification.* Class II (special controls); guidance document (Class II Special Controls Guidance for Home Uterine Activity Monitors).

## Recent Cleared Devices (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K221046](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/LQK/K221046.md) | Invu by Nuvo | Nuvo- Group , Ltd. | May 6, 2022 | SESE |
| [K210025](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/LQK/K210025.md) | INVU by Nuvo | Nuvo- Group , Ltd. | May 28, 2021 | SESE |
| [K191401](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/LQK/K191401.md) | PregSense | Nuvo- Group , Ltd. | Mar 27, 2020 | SESE |
| [K143114](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/LQK/K143114.md) | Sense4Baby System Model B+ (MSA) | Airstrip Technologies, Inc. | Mar 10, 2015 | SESE |
| [K020390](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/LQK/K020390.md) | MODIFICATION TO FETAL ASSIST | Huntleigh Diagnostics , Ltd. | Apr 19, 2002 | SESE |
| [P920038](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/LQK/P920038.md) | SYSTEM 37 HOME UTERINE ACTIVITY MONITORING SYSTEM | Matria Healthcare, Inc. | Sep 29, 1995 | APRL |
| [P910063](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/LQK/P910063.md) | CAREFONE(TM)HOME UTERINE ACTIVITY MONITOR SYSTEM | Matria Healthcare, Inc. | Sep 29, 1995 | APRL |

## Top Applicants

- Nuvo- Group , Ltd. — 3 clearances
- Matria Healthcare, Inc. — 2 clearances
- Airstrip Technologies, Inc. — 1 clearance
- Huntleigh Diagnostics , Ltd. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/LQK](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/LQK)

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