Cleared Traditional

K123335 - SUNRAY FETAL MONITOR

K123335 is an FDA 510(k) clearance for SUNRAY FETAL MONITOR, manufactured by Sunray Medical Apparatus Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K123335 · Sunray Medical Apparatus Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K123335

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 161d · This submission: 146d
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 185
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K123335.
FETAL MONITORS
K131941 · Guangdong Biolight Meditech Co., Ltd. · May 2014
SONICAID FREEDOM WIRELESS FETAL MONITORING SYSTEM
K132650 · Huntleigh Healthcare Limited · Feb 2014
SENSE-4BABY SYSTEM
K132918 · Sense4baby , Inc. · Nov 2013
CERNER FETALINK+(VERSION1.0)
K121758 · Cerner Corp. · Oct 2012
MINDCHILD MERIDIAN FETAL HEART RATE MONITOR
K120018 · Mindchild Medical · Sep 2012
BT-200V VASCULAR DOPPLER
K121267 · Bistos Co., Ltd. · Aug 2012
K123335 · SUNRAY FETAL MONITOR
Download PDF FDA Summary Sunray Medical Appara…