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 884.2720](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/884.2720) → OSP — Uterine Electromyographic Monitor

# OSP · Uterine Electromyographic Monitor

_Obstetrics/Gynecology · 21 CFR 884.2720 · Class 2_

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

## Overview

- **Product Code:** OSP
- **Device Name:** Uterine Electromyographic Monitor
- **Regulation:** [21 CFR 884.2720](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/884.2720)
- **Device Class:** 2
- **Review Panel:** [Obstetrics/Gynecology](/submissions/OB)

## Identification

An external uterine contraction monitor (i.e., the tokodynamometer) is a device used to monitor the progress of labor. It measures the duration, frequency, and relative pressure of uterine contractions with a transducer strapped to the maternal abdomen. This generic type of device may include an external pressure transducer, support straps, and other patient and equipment supports.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (10 of 10)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K190798](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/OSP/K190798.md) | LaborView™ LV1000 Wireless Electrode System | Obmedical Company | Sep 18, 2020 | SESE |
| [K153262](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/OSP/K153262.md) | PUREtrace™ | Nemo Healthcare BV | Feb 7, 2017 | SESE |
| [K142583](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/OSP/K142583.md) | LaborView LV1000 | Obmedical Company | Jan 16, 2015 | SESE |
| [K140862](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/OSP/K140862.md) | MONICA NOVII WIRELESS PATCH SYSTEM | Monica Healthcare, Ltd. | Aug 27, 2014 | SESE |
| [K131889](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/OSP/K131889.md) | EUM 100PRO | Promedic, Inc. | Apr 23, 2014 | SESE |
| [K130002](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/OSP/K130002.md) | SURECALL LABOR MONITOR | Reproductive Research Technologies, LP | Jun 28, 2013 | SESE |
| [K112390](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/OSP/K112390.md) | MONICA AN24 | Monica Healthcare, Ltd. | Jul 13, 2012 | SESE |
| [K112163](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/OSP/K112163.md) | MONICA IF24 | Monica Healthcare | Aug 30, 2011 | SESE |
| [K101801](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/OSP/K101801.md) | MONICA AN24 | Monica Healthcare | Feb 3, 2011 | SESE |
| [K090145](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/OSP/K090145.md) | SURECALL EMG LABOR MONITOR | Reproductive Research Technologies, LP | Jan 25, 2011 | SESE |

## Top Applicants

- Monica Healthcare — 2 clearances
- Monica Healthcare, Ltd. — 2 clearances
- Obmedical Company — 2 clearances
- Reproductive Research Technologies, LP — 2 clearances
- Nemo Healthcare BV — 1 clearance

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

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