Cleared Traditional

CLINICAL INFOR SYST(CIS) W/FETAL MONIT REMOTE DISP (K931133) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K931133 · Clinicomp, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
754d
Days
Class 2
Risk

K931133 is an FDA 510(k) clearance for the CLINICAL INFOR SYST(CIS) W/FETAL MONIT REMOTE DISP. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Clinicomp, Inc. (San Diego, US). The FDA issued a Cleared decision on March 29, 1995 after a review of 754 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Clinicomp, Inc. devices

Submission Details

510(k) Number K931133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1993
Decision Date March 29, 1995
Days to Decision 754 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
594d slower than avg
Panel avg: 160d · This submission: 754d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K931133.
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
MODEL 118 FETAL/MATERNAL MONITOR
K934959 · Ge Medical Systems Information Technologies · Aug 1994
MODEL M1310A, SERIES 50T FETAL TELEMETRY SYSTEM
K942887 · Hewlett-Packard Co. · Aug 1994
MODEL 151 FETAL MONITOR
K932077 · Ge Medical Systems Information Technologies · Mar 1994