Cleared Traditional

K173042 - Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express (FDA 510(k) Clearance)

Also includes:
Fetal Monitor: Models F2, F3

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K173042 · Edan Instruments, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2018
Decision
336d
Days
Class 2
Risk

K173042 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 August 30, 2018 after a review of 336 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Edan Instruments, Inc. devices

Submission Details

510(k) Number K173042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2017
Decision Date August 30, 2018
Days to Decision 336 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
176d slower than avg
Panel avg: 160d · This submission: 336d
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 Peers - HGM System, Monitoring, Perinatal

All 213
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K173042.
ANNE Maternal
K253021 · Sibel Health, Inc. · Feb 2026
Sonicaid Team3
K250777 · Huntleigh Healthcare , Ltd. · Sep 2025
Fetal & Maternal Monitor (F15A, F15A Air)
K241882 · Edan Instruments, Inc. · Aug 2025
Sonicaid Team3
K241368 · Huntleigh Healthcare , Ltd. · Feb 2025
PeriCALM Patterns 3.0
K241009 · Perigen, Inc. · Jan 2025
Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)
K233440 · Philips Medizin Systeme Boeblingen GmbH · Jul 2024