Cleared Special

K021135 - MODEL 2120IS SERIES MATERNAL/FETAL MONITOR

K021135 is an FDA 510(k) clearance for MODEL 2120IS SERIES MATERNAL/FETAL MONITOR, manufactured by Ge Medical Systems Information Technologies. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Special 510(k) pathway after a 30-day FDA review.

K021135 · Ge Medical Systems Information Technologies · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
30d
Days
Class 2
Risk

K021135 is an FDA 510(k) clearance for the MODEL 2120IS SERIES MATERNAL/FETAL MONITOR. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies (Wallingford, US). The FDA issued a Cleared decision on May 9, 2002 after a review of 30 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 Medical Systems Information Technologies devices

FDA 510(k) Submission Details - K021135

510(k) Number K021135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2002
Decision Date May 09, 2002
Days to Decision 30 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
130d faster than avg
Panel avg: 160d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

HGM Device Classification - Class 2, Special Controls

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 99
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K021135.
MODEL 120 SERIES MATERNAL/FETAL MONITOR
K032252 · Ge Medical Systems Information Technologies · Aug 2003
PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M2720A, M2725A, M2726A, M2727A
K023931 · Philips Medical Systems, Inc. · Feb 2003
TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER
K021574 · Card Guard Scientific Survival , Ltd. · Aug 2002
MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM.
K012718 · Ge Medical Systems Information Technologies · Nov 2001
OB-1 FETAL MONITOR
K011304 · Analogic Corp. · May 2001
CG-900P FETAL/MATERNAL MONITOR
K010552 · Card Guard Scientific Survival , Ltd. · May 2001