Cleared Traditional

K992607 - SONICAID SYSTEM 8002

K992607 is an FDA 510(k) clearance for SONICAID SYSTEM 8002, manufactured by Oxford Instruments Medical Systems. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Traditional 510(k) pathway after a 633-day FDA review.

K992607 · Oxford Instruments Medical Systems · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
633d
Days
Class 2
Risk

K992607 is an FDA 510(k) clearance for the SONICAID SYSTEM 8002. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Oxford Instruments Medical Systems (Crofton, US). The FDA issued a Cleared decision on April 27, 2001 after a review of 633 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 Oxford Instruments Medical Systems devices

FDA 510(k) Submission Details - K992607

510(k) Number K992607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1999
Decision Date April 27, 2001
Days to Decision 633 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
473d slower than avg
Panel avg: 160d · This submission: 633d
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 123
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K992607.
MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM.
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OB-1 FETAL MONITOR
K011304 · Analogic Corp. · May 2001
CG-900P FETAL/MATERNAL MONITOR
K010552 · Card Guard Scientific Survival , Ltd. · May 2001
FETALGARD LITE
K002503 · Analogic Corp. · Nov 2000
COROMETRICS MODEL 173 FETAL MONITOR
K993751 · Ge Medical Systems Information Technologies · Feb 2000
COROMETRICS MODEL 171 AND 172 FETAL MONITOR
K991905 · General Electric Medical Systems Information Techn · Sep 1999