Cleared Traditional

K090145 - SURECALL EMG LABOR MONITOR

K090145 is an FDA 510(k) clearance for SURECALL EMG LABOR MONITOR, manufactured by Reproductive Research Technologies, LP. The device is a Class 2 Obstetrics & Gynecology device with product code OSP cleared through the Traditional 510(k) pathway after a 734-day FDA review.

K090145 · Reproductive Research Technologies, LP · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
734d
Days
Class 2
Risk

K090145 is an FDA 510(k) clearance for the SURECALL EMG LABOR MONITOR. Classified as Uterine Electromyographic Monitor (product code OSP), Class II - Special Controls.

Submitted by Reproductive Research Technologies, LP (Houston, US). The FDA issued a Cleared decision on January 25, 2011 after a review of 734 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

FDA 510(k) Submission Details - K090145

510(k) Number K090145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2009
Decision Date January 25, 2011
Days to Decision 734 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
573d slower than avg
Panel avg: 161d · This submission: 734d
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.

Clinical Evidence

ClinicalTrials.gov
NCT01282710 Completed Observational Industry-sponsored

Comparison of SureCALL® EMG Labor Monitor® and Tocodynamometer to Intrauterine Pressure Catheter Measurement (IUPC) Measurement in Pregnant Women

Comparison of SureCALL® EMG Labor Monitor® and Tocodynamometer to Intrauterine Pressure Catheter Measurement in Pregnant Women

20
Patients (actual)
3
Sites
Condition studied Pregnancy - Labor Monitoring
Eligibility Female only · 15 Years+
Principal investigator Timothy B Waterhouse, MD
Sponsor Reproductive Research Technologies, LP (industry)
Started 2008-08-01 → Primary completion 2008-12-01
Primary outcome
Comparison of SureCALL® and TOCO Detection of Contraction Events, as Compared to the IUPC
View full study on ClinicalTrials.gov
K090145 · SURECALL EMG LABOR MONITOR
Download PDF FDA Summary Reproductive Research…