Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart C — Obstetrical and Gynecological Monitoring Devices](/submissions/OP/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices) → [21 CFR 884.2800](/submissions/OP/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/884.2800) → NPB — System, Monitoring, For Progress Of Labor

# NPB · System, Monitoring, For Progress Of Labor

_Ophthalmic · 21 CFR 884.2800 · Class 2_

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

## Overview

- **Product Code:** NPB
- **Device Name:** System, Monitoring, For Progress Of Labor
- **Regulation:** [21 CFR 884.2800](/submissions/OP/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/884.2800)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)

## Identification

A computerized labor monitoring system is a system intended to continuously measure cervical dilation and fetal head descent and provide a display that indicates the progress of labor. The computerized labor monitoring system includes a monitor and ultrasound transducers. Ultrasound transducers are placed on the maternal abdomen and cervix and on the fetal scalp to provide the matrix of measurements used to produce the display.

## Classification Rationale

Class II (special controls). The special controls are the FDA guidance document entitled: “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Computerized Labor Monitoring Systems.” See § 884.1(e) for availability of this guidance document.

## Special Controls

*Classification.* Class II (special controls). The special controls are the FDA guidance document entitled: “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Computerized Labor Monitoring Systems.” See § 884.1(e) for availability of this guidance document.

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K081984](https://fda.innolitics.com/submissions/OP/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/NPB/K081984.md) | LABORPRO SYSTEM | Trig Medical, Ltd. | Mar 4, 2009 | SESE |
| [K082704](https://fda.innolitics.com/submissions/OP/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/NPB/K082704.md) | BIRTHTRACK (A.K.A. CLM) | Barnev, Ltd. | Jan 9, 2009 | SESE |
| [K080672](https://fda.innolitics.com/submissions/OP/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/NPB/K080672.md) | BIRTHTRACK | Barnev, Ltd. | Jul 8, 2008 | SESE |
| [DEN060006](https://fda.innolitics.com/submissions/OP/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/NPB/DEN060006.md) | COMPUTERIZED LABOR MONITORING SYSTEM | Barnev, Ltd. | Jan 30, 2007 | DENG |

## Top Applicants

- Barnev, Ltd. — 3 clearances
- Trig Medical, Ltd. — 1 clearance

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

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