Cleared Special

CG-900P FETAL/MATERNAL MONITOR (K010552) - FDA 510(k) Clearance

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

K010552 · Card Guard Scientific Survival , Ltd. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
May 2001
Decision
74d
Days
Class 2
Risk

K010552 is an FDA 510(k) clearance for the CG-900P FETAL/MATERNAL MONITOR. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Card Guard Scientific Survival , Ltd. (Rehovot, IL). The FDA issued a Cleared decision on May 11, 2001 after a review of 74 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 Card Guard Scientific Survival , Ltd. devices

Submission Details

510(k) Number K010552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2001
Decision Date May 11, 2001
Days to Decision 74 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 160d · This submission: 74d
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 56
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K010552.
MODEL 120 SERIES MATERNAL/FETAL MONITOR
K032252 · Ge Medical Systems Information Technologies · Aug 2003
MODEL 2120IS SERIES MATERNAL/FETAL MONITOR
K021135 · Ge Medical Systems Information Technologies · May 2002
MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM.
K012718 · Ge Medical Systems Information Technologies · Nov 2001
COROMETRICS MODEL 173 FETAL MONITOR
K993751 · Ge Medical Systems Information Technologies · Feb 2000
COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR
K964770 · Ge Medical Systems Information Technologies · Feb 1997
COROMETRICS FETAL MOVEMENT DETECTION KIT
K955559 · Ge Medical Systems Information Technologies · Mar 1996