Cleared Traditional

MODEL SONICAID AXIS (K912890) - FDA 510(k) Clearance

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

K912890 · Oxford Medilog, Inc. · Obstetrics & Gynecology device
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Jan 1992
Decision
192d
Days
Class 2
Risk

K912890 is an FDA 510(k) clearance for the MODEL SONICAID AXIS. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Oxford Medilog, Inc. (Clearwater, US). The FDA issued a Cleared decision on January 9, 1992 after a review of 192 days - an extended review 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: 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 Oxford Medilog, Inc. devices

Submission Details

510(k) Number K912890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1991
Decision Date January 09, 1992
Days to Decision 192 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
32d slower than avg
Panel avg: 160d · This submission: 192d
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 29
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K912890.
MODEL M1310A, SERIES 50T FETAL TELEMETRY SYSTEM
K942887 · Hewlett-Packard Co. · Aug 1994
HEWLETT PACKARD MODEL M1353A FETAL MONITOR
K921956 · Hewlett-Packard Co. · Sep 1993
HEWLETT-PACKARD MODEL M1351A FETAL MONITOR
K921957 · Hewlett-Packard Co. · Sep 1993
M1350A FETAL MONITOR (INTRAPARTUM)
K900480 · Hewlett-Packard Co. · Jul 1990
ODIS - OBSTETRICAL DISPLAY INFO SYSTEM, HP M1370A
K892354 · Hewlett-Packard Co. · Aug 1989
OMF-7101 FETAL MONITOR
K860237 · Nihon Kohden America, Inc. · Sep 1986