Cleared Special

K023618 - SONICAID ONE

K023618 is an FDA 510(k) clearance for SONICAID ONE, manufactured by Oxford Instruments Medical , Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Special 510(k) pathway after a 85-day FDA review.

K023618 · Oxford Instruments Medical , Ltd. · Obstetrics & Gynecology device
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Jan 2003
Decision
85d
Days
Class 2
Risk

K023618 is an FDA 510(k) clearance for the SONICAID ONE. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Oxford Instruments Medical , Ltd. (Old Woking, Surrey, GB). The FDA issued a Cleared decision on January 22, 2003 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2740 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Oxford Instruments Medical , Ltd. devices

FDA 510(k) Submission Details - K023618

510(k) Number K023618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2002
Decision Date January 22, 2003
Days to Decision 85 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 160d · This submission: 85d
Pathway characteristics
Modification to existing cleared device.

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 148
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