OSPClass II

Uterine Electromyographic Monitor

21 CFR 884.2720 / Obstetrics/Gynecology

OSP is the FDA product code for Uterine Electromyographic Monitor, a class II device type, regulated under 21 CFR 884.2720. FDA's definition for this code reads: "The uterine electromyographic monitor is intended to pick up uterine emg signals from surface electrodes placed on the maternal abdomen. It produces a uterine activity tracing and monitors women in labor at term gestation with a singleton pregnancy". As of 2026-09-10, FDA records hold 10 510(k) clearances under this code, the most recent dated 2020-09-18, and 3 recalls.

Classification record

Product code: OSP
Device name: Uterine Electromyographic Monitor
FDA definition: The uterine electromyographic monitor is intended to pick up uterine emg signals from surface electrodes placed on the maternal abdomen. It produces a uterine activity tracing and monitors women in labor at term gestation with a singleton pregnancy.
Regulation: 21 CFR 884.2720
Device class: Class II
Review panel: Obstetrics/Gynecology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 10
Ingested recalls: 3

Clearances, product code OSP

By decision year

10 clearances under product code OSP with a decision year between 2011 and 2020, 2011 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code OSP by decision year
Year	Clearances
2011	3
2012	1
2013	1
2014	2
2015	1
2017	1
2020	1

Applicants with the most clearances

Product code OSP

Applicants holding the most 510(k) clearances under product code OSP
Applicant	Clearances
Monica Healthcare	4
Obmedical Company	2
Reproductive Research Technologies, LP	2
Nemo Healthcare BV	1
Promedic, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code