Cleared Traditional

K120018 - MINDCHILD MERIDIAN FETAL HEART RATE MONITOR

K120018 is an FDA 510(k) clearance for MINDCHILD MERIDIAN FETAL HEART RATE MONITOR, manufactured by Mindchild Medical. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K120018 · Mindchild Medical · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
260d
Days
Class 2
Risk

K120018 is an FDA 510(k) clearance for the MINDCHILD MERIDIAN FETAL HEART RATE MONITOR. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Mindchild Medical (Providence, US). The FDA issued a Cleared decision on September 19, 2012 after a review of 260 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.

FDA 510(k) Submission Details - K120018

510(k) Number K120018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2012
Decision Date September 19, 2012
Days to Decision 260 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
99d slower than avg
Panel avg: 161d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - HGM System, Monitoring, Perinatal

All 183
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K120018.
SENSE-4BABY SYSTEM
K132918 · Sense4baby , Inc. · Nov 2013
SUNRAY FETAL MONITOR
K123335 · Sunray Medical Apparatus Co., Ltd. · Mar 2013
CERNER FETALINK+(VERSION1.0)
K121758 · Cerner Corp. · Oct 2012
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