Cleared Traditional

K110612 - FM20

K110612 is an FDA 510(k) clearance for FM20, manufactured by Mediana Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Traditional 510(k) pathway after a 250-day FDA review.

K110612 · Mediana Co., Ltd. · Obstetrics & Gynecology device
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Nov 2011
Decision
250d
Days
Class 2
Risk

K110612 is an FDA 510(k) clearance for the FM20. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Mediana Co., Ltd. (Wonju-Si, Gangwon-Do, KR). The FDA issued a Cleared decision on November 8, 2011 after a review of 250 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 Mediana Co., Ltd. devices

FDA 510(k) Submission Details - K110612

510(k) Number K110612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2011
Decision Date November 08, 2011
Days to Decision 250 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 160d · This submission: 250d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HGM System, Monitoring, Perinatal

All 155
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K110612.
BT-200V VASCULAR DOPPLER
K121267 · Bistos Co., Ltd. · Aug 2012
OBIX PERINATAL DATA SYSTEM 7.0
K121208 · Clinical Computer Systems, Inc. · Jun 2012
FM-9000 PLUS FETAL AND MATERNAL MONITOR
K112317 · Advanced Instrumentations, Inc. · Dec 2011
CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE
K111614 · Ge Healthcare Integrated IT Solutions · Sep 2011
CMS-1000FM CENTRAL MONITORING SYSTEM
K112159 · Advanced Instrumentations, Inc. · Sep 2011
FM-1000 PLUS FETAL MONITOR
K112187 · Advanced Instrumentations, Inc. · Sep 2011

FDA 510(k) Resources - Obstetrics & Gynecology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.