Cleared Traditional

K131889 - EUM 100PRO (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K131889 · Promedic, Inc. · Obstetrics & Gynecology device
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Apr 2014
Decision
302d
Days
Class 2
Risk

K131889 is an FDA 510(k) clearance for the EUM 100PRO. Classified as Uterine Electromyographic Monitor (product code OSP), Class II - Special Controls.

Submitted by Promedic, Inc. (Bonita Springs, US). The FDA issued a Cleared decision on April 23, 2014 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Promedic, Inc. devices

Submission Details

510(k) Number K131889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2013
Decision Date April 23, 2014
Days to Decision 302 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 160d · This submission: 302d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.