Cleared Traditional

K150901 - Fetal & Maternal Monitor

K150901 is the FDA 510(k) clearance for Fetal & Maternal Monitor by Edan Instruments, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HGM) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K150901 · Edan Instruments, Inc. · Obstetrics & Gynecology device
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Jul 2015
Decision
89d
Days
Class 2
Risk

K150901 is an FDA 510(k) clearance for the Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on July 1, 2015 after a review of 89 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Edan Instruments, Inc. devices

Submission Details

510(k) Number K150901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2015
Decision Date July 01, 2015
Days to Decision 89 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
71d faster than avg
Panel avg: 160d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

Edan Medical
Doug Worth

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 65
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K150901.
Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express
K173042 · Edan Instruments, Inc. · Aug 2018
AlertWatch:OB
K173715 · Alertwatch, Inc. · Apr 2018
Central Monitoring System
K171178 · Edan Instruments, Inc. · Sep 2017
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