Cleared Special

K072976 - MODEL 250CX SERIES MATERNAL/FETAL MONITOR

K072976 is the FDA 510(k) clearance for MODEL 250CX SERIES MATERNAL/FETAL MONITOR by Ge Healthcare. It is a Class 2 Obstetrics & Gynecology device (product code HGM) cleared through the Special 510(k) pathway after a 56-day FDA review.

K072976 · Ge Healthcare · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2007
Decision
56d
Days
Class 2
Risk

K072976 is an FDA 510(k) clearance for the MODEL 250CX SERIES MATERNAL/FETAL MONITOR. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Ge Healthcare (Laurel, US). The FDA issued a Cleared decision on December 20, 2007 after a review of 56 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ge Healthcare devices

Submission Details

510(k) Number K072976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2007
Decision Date December 20, 2007
Days to Decision 56 days
Submission Type Special
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
104d faster than avg
Panel avg: 160d · This submission: 56d
Pathway characteristics
Modification to existing cleared device.

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 88
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K072976.
CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR
K082369 · Edan Instruments, Inc. · Nov 2008
OB TRACEVUE OBSTETRICAL INFORMATION MANAGEMENT SYSTEM WITH RELEASE F.00
K081203 · Philips Medizin Systeme Boeblingen GmbH · May 2008
CADENCE II
K073221 · Edan Instruments, Inc. · Dec 2007
MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30
K062137 · Philips Medizin Systeme Boeblingen GmbH · Aug 2006
PHILIPS AVALON FETAL MONITOR, MODELS FM20 AND FM30
K052795 · Philips Medizin Systeme Boeblingen GmbH · Dec 2005
MODEL 250 SERIES MATERNAL/FETAL MONITOR
K050583 · Ge Medical Systems Information Technologies · Jun 2005