Cleared Traditional

K991905 - COROMETRICS MODEL 171 AND 172 FETAL MONITOR

K991905 is an FDA 510(k) clearance for COROMETRICS MODEL 171 AND 172 FETAL MONITOR, manufactured by General Electric Medical Systems Information Techn. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K991905 · General Electric Medical Systems Information Techn · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
89d
Days
Class 2
Risk

K991905 is an FDA 510(k) clearance for the COROMETRICS MODEL 171 AND 172 FETAL MONITOR. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by General Electric Medical Systems Information Techn (Wallingford, US). The FDA issued a Cleared decision on September 1, 1999 after a review of 89 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all General Electric Medical Systems Information Techn devices

FDA 510(k) Submission Details - K991905

510(k) Number K991905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1999
Decision Date September 01, 1999
Days to Decision 89 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
71d faster than avg
Panel avg: 160d · This submission: 89d
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 162
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K991905.
COROMETRICS MODEL 173 FETAL MONITOR
K993751 · Ge Medical Systems Information Technologies · Feb 2000
BABY DOPPLEX 4000, MODEL BD 4000
K990569 · Huntleigh Healthcare, Inc. · Jan 2000
QUANTITATIVE SENTINEL SYSTEM
K993008 · Marquette Medical Systems, Inc. · Dec 1999
COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR
K991739 · General Electric Medical Systems Information Techn · Aug 1999
FETALGARD 3000 FETAL MONITOR
K983395 · Analogic Corp. · Aug 1999
WATCHCHILD OBSTERICAL PATIENT DATA MANAGEMENT SYSTEM
K974248 · Air-Shields, Inc. · Oct 1998