Cleared Abbreviated

PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50 (K140535) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K140535 · Philips Medizin Systeme Boblingen GmbH · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2014
Decision
266d
Days
Class 2
Risk

K140535 is an FDA 510(k) clearance for the PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Philips Medizin Systeme Boblingen GmbH (Boeblingen, DE). The FDA issued a Cleared decision on November 25, 2014 after a review of 266 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Philips Medizin Systeme Boblingen GmbH devices

Submission Details

510(k) Number K140535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2014
Decision Date November 25, 2014
Days to Decision 266 days
Submission Type Abbreviated
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 160d · This submission: 266d
Pathway characteristics
Standards-based clearance path.

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 57
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K140535.
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
MODEL 250CX SERIES MATERNAL/FETAL MONITOR
K072976 · Ge Healthcare · Dec 2007
MODEL 250 SERIES MATERNAL/FETAL MONITOR
K050583 · Ge Medical Systems Information Technologies · Jun 2005
MODEL 120 SERIES MATERNAL/FETAL MONITOR
K032252 · Ge Medical Systems Information Technologies · Aug 2003