Cleared Traditional

K142583 - LaborView LV1000

K142583 is an FDA 510(k) clearance for LaborView LV1000, manufactured by Obmedical Company. The device is a Class 2 Obstetrics & Gynecology device with product code OSP cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K142583 · Obmedical Company · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2015
Decision
123d
Days
Class 2
Risk

K142583 is an FDA 510(k) clearance for the LaborView LV1000. Classified as Uterine Electromyographic Monitor (product code OSP), Class II - Special Controls.

Submitted by Obmedical Company (Newberry, US). The FDA issued a Cleared decision on January 16, 2015 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2720 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Obmedical Company devices

FDA 510(k) Submission Details - K142583

510(k) Number K142583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2014
Decision Date January 16, 2015
Days to Decision 123 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 160d · This submission: 123d
Pathway characteristics
Predicate-based equivalence.

OSP Device Classification - Class 2, Special Controls

Product Code OSP Uterine Electromyographic Monitor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2720
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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Consultant

Promedic, Inc.
PAUL DRYDEN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT01400880 Completed Interventional Industry-sponsored

Electrode-based Sensor for Non-invasive Fetal Heart Rate and EMG Monitoring With Improved Reliability

103
Patients (actual)
1
Site
Device_feasibility
Purpose
Open label
Masking
Condition studied Pregnancy
Study design Single group
Eligibility Female only · 18 Years+ · Healthy volunteers accepted
Principal investigator Anthony Gregg, PhD
Sponsor Convergent Engineering, Inc. (industry)
Started 2011-07-01 → Primary completion 2014-04-01
Primary outcome
Comparison of Electrode Sensor and TOCO Detection of Contraction Events, as Compared to IUPC
View full study on ClinicalTrials.gov

Regulatory Peers - OSP Uterine Electromyographic Monitor

All 7
Devices cleared under the same product code (OSP) and FDA review panel - the closest regulatory comparables to K142583.
LaborView™ LV1000 Wireless Electrode System
K190798 · Obmedical Company · Sep 2020
PUREtrace™
K153262 · Nemo Healthcare BV · Feb 2017
MONICA NOVII WIRELESS PATCH SYSTEM
K140862 · Monica Healthcare, Ltd. · Aug 2014
EUM 100PRO
K131889 · Promedic, Inc. · Apr 2014
SURECALL LABOR MONITOR
K130002 · Reproductive Research Technologies, LP · Jun 2013
MONICA AN24
K112390 · Monica Healthcare, Ltd. · Jul 2012