Cleared Traditional

K110612 - FM20

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

K110612 · Mediana Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
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.

Device Classification

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 89
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K110612.
Central Monitoring System
K171178 · Edan Instruments, Inc. · Sep 2017
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, MODELS F2 AND F3
K102140 · Edan Instruments, Inc. · Jan 2011
CENTRAL MONITORING SYSTEM
K100358 · Edan Instruments, Inc. · Jan 2011
FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS
K100797 · Edan Instruments, Inc. · Nov 2010