Cleared Traditional

SUNRAY FETAL MONITOR (K123335) - FDA 510(k) Clearance

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

K123335 · Sunray Medical Apparatus Co., Ltd. · Obstetrics & Gynecology device
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Mar 2013
Decision
146d
Days
Class 2
Risk

K123335 is an FDA 510(k) clearance for the SUNRAY FETAL MONITOR. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Sunray Medical Apparatus Co., Ltd. (Shenzhen, Guangdong, CN). The FDA issued a Cleared decision on March 21, 2013 after a review of 146 days - within the typical 510(k) review window.

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 Sunray Medical Apparatus Co., Ltd. devices

Submission Details

510(k) Number K123335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2012
Decision Date March 21, 2013
Days to Decision 146 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
14d faster than avg
Panel avg: 160d · This submission: 146d
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 213
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