Cleared Traditional

K142883 - MindChild Meridian M100 Fetal Heart Rate Monitor

K142883 is an FDA 510(k) clearance for MindChild Meridian M100 Fetal Heart Rat..., 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 197-day FDA review.

K142883 · Mindchild Medical · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
197d
Days
Class 2
Risk

K142883 is an FDA 510(k) clearance for the MindChild Meridian M100 Fetal Heart Rate Monitor. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Mindchild Medical (North Andover, US). The FDA issued a Cleared decision on April 17, 2015 after a review of 197 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 - K142883

510(k) Number K142883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2014
Decision Date April 17, 2015
Days to Decision 197 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
36d slower than avg
Panel avg: 161d · This submission: 197d
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 Consultant

Northstar Biomedical Associates
Leo Basta

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 183
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K142883.
EUM 100Pro
K150398 · Ob Tools, Ltd. · Aug 2015
Model BT-220L and BT-220C
K142799 · Bistos Co., Ltd. · Jul 2015
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
PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50
K140535 · Philips Medizin Systeme Boblingen GmbH · Nov 2014
FM-3000 FETAL MONITOR
K141194 · Advanced Instrumentations, Inc. · Nov 2014