Cleared Traditional

MONICA IF24 (K112163) - FDA 510(k) Clearance

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

K112163 · Monica Healthcare · Obstetrics & Gynecology device
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Aug 2011
Decision
34d
Days
Class 2
Risk

K112163 is an FDA 510(k) clearance for the MONICA IF24. Classified as Uterine Electromyographic Monitor (product code OSP), Class II - Special Controls.

Submitted by Monica Healthcare (Nottingham, GB). The FDA issued a Cleared decision on August 30, 2011 after a review of 34 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K112163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2011
Decision Date August 30, 2011
Days to Decision 34 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
126d faster than avg
Panel avg: 160d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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.