Cleared Traditional

K150398 - EUM 100Pro

K150398 is an FDA 510(k) clearance for EUM 100Pro, manufactured by Ob Tools, Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K150398 · Ob Tools, Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
169d
Days
Class 2
Risk

K150398 is an FDA 510(k) clearance for the EUM 100Pro. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Ob Tools, Ltd. (Migdal Ha-Emek, IL). The FDA issued a Cleared decision on August 6, 2015 after a review of 169 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2740 - 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 Ob Tools, Ltd. devices

FDA 510(k) Submission Details - K150398

510(k) Number K150398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2015
Decision Date August 06, 2015
Days to Decision 169 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
9d slower than avg
Panel avg: 160d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HGM Device Classification - Class 2, Special Controls

Product Code HGM System, Monitoring, Perinatal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2740
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.

Regulatory Peers - HGM System, Monitoring, Perinatal

All 104
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K150398.
AlertWatch:OB
K173715 · Alertwatch, Inc. · Apr 2018
Central Monitoring System
K171178 · Edan Instruments, Inc. · Sep 2017
Central Monitoring System
K153580 · Guangdong Biolight Meditech Co., Ltd. · Sep 2016
Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express
K150901 · Edan Instruments, Inc. · Jul 2015
CENTRAL MONITORING SYSTEM
K143695 · Edan Instruments, Inc. · Mar 2015
FETAL MONITORS
K131941 · Guangdong Biolight Meditech Co., Ltd. · May 2014