Cleared Traditional

HOMEVUE MONITORING SYS.MODEL TD 2000 (K912138) - FDA 510(k) Clearance

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

K912138 · Homevue Health Systems, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1992
Decision
310d
Days
Class 2
Risk

K912138 is an FDA 510(k) clearance for the HOMEVUE MONITORING SYS.MODEL TD 2000. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Homevue Health Systems, Inc. (Laguna Beach, US). The FDA issued a Cleared decision on March 19, 1992 after a review of 310 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Homevue Health Systems, Inc. devices

Submission Details

510(k) Number K912138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1991
Decision Date March 19, 1992
Days to Decision 310 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
150d slower than avg
Panel avg: 160d · This submission: 310d
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 46
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K912138.
HEWLETT PACKARD MODEL M1353A FETAL MONITOR
K921956 · Hewlett-Packard Co. · Sep 1993
HEWLETT-PACKARD MODEL M1351A FETAL MONITOR
K921957 · Hewlett-Packard Co. · Sep 1993
COROMETRICS MODEL 150 FETAL MONITOR
K920376 · Ge Medical Systems Information Technologies · Apr 1992
COROMETRICS MDL 330 FETAL/MATERNAL TELEMETRY SYST
K910260 · Ge Medical Systems Information Technologies · Mar 1991
CATALOG NUMBER 2609 LEG PLATE
K905295 · Ge Medical Systems Information Technologies · Feb 1991
MODEL 855 ENHANCED PERFORMANCE REMOTE TERMINAL
K904358 · Ge Medical Systems Information Technologies · Oct 1990