Cleared Traditional

K955559 - COROMETRICS FETAL MOVEMENT DETECTION KIT

K955559 is an FDA 510(k) clearance for COROMETRICS FETAL MOVEMENT DETECTION KIT, manufactured by Ge Medical Systems Information Technologies. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K955559 · Ge Medical Systems Information Technologies · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
90d
Days
Class 2
Risk

K955559 is an FDA 510(k) clearance for the COROMETRICS FETAL MOVEMENT DETECTION KIT. 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 March 5, 1996 after a review of 90 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Ge Medical Systems Information Technologies devices

FDA 510(k) Submission Details - K955559

510(k) Number K955559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1995
Decision Date March 05, 1996
Days to Decision 90 days
Submission Type Traditional
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
70d faster than avg
Panel avg: 160d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K955559.
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS5169
K971099 · Alexander Mfg. Co. · Jun 1997
CARD GUARD MODEL CG-900
K960553 · Card Guard Scientific Survival , Ltd. · Apr 1997
COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR
K964770 · Ge Medical Systems Information Technologies · Feb 1997
FETALGARD 3000 - MODELS IP1, IP2, AP2 AND AP3
K950420 · Analogic Corp. · May 1995
R & D BATTERIES, INC. PART NUMBERS 5235, 5506 & 5050
K935301 · R & D Batteries, Inc. · Dec 1994
R AND D BATTERIES
K935377 · R & D Batteries, Inc. · Dec 1994