Cleared Traditional

K130002 - SURECALL LABOR MONITOR

K130002 is an FDA 510(k) clearance for SURECALL 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 177-day FDA review.

K130002 · 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
Jun 2013
Decision
177d
Days
Class 2
Risk

K130002 is an FDA 510(k) clearance for the SURECALL 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 June 28, 2013 after a review of 177 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K130002

510(k) Number K130002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2013
Decision Date June 28, 2013
Days to Decision 177 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
16d slower than avg
Panel avg: 161d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. 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 - OSP Uterine Electromyographic Monitor

All 9
Devices cleared under the same product code (OSP) and FDA review panel - the closest regulatory comparables to K130002.
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EUM 100PRO
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MONICA AN24
K112390 · Monica Healthcare, Ltd. · Jul 2012
MONICA IF24
K112163 · Monica Healthcare · Aug 2011
MONICA AN24
K101801 · Monica Healthcare · Feb 2011
K130002 · SURECALL LABOR MONITOR
Download PDF FDA Summary Reproductive Research…