Cleared Traditional

K912138 - HOMEVUE MONITORING SYS.MODEL TD 2000

K912138 is an FDA 510(k) clearance for HOMEVUE MONITORING SYS.MODEL TD 2000, manufactured by Homevue Health Systems, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Traditional 510(k) pathway after a 310-day FDA review.

K912138 · Homevue Health Systems, Inc. · Obstetrics & Gynecology device
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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

FDA 510(k) Submission Details - K912138

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.

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 104
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
MODEL SONICAID AXIS
K912890 · Oxford Medilog, Inc. · Jan 1992
SONICAID TEAM
K912639 · Oxford Medilog, Inc. · Dec 1991
FETALGARD 2000
K910169 · Analogic Corp. · Jul 1991