Cleared Traditional

K153580 - Central Monitoring System

K153580 is an FDA 510(k) clearance for Central Monitoring System, manufactured by Guangdong Biolight Meditech Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K153580 · Guangdong Biolight Meditech Co., Ltd. · Obstetrics & Gynecology device
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Sep 2016
Decision
267d
Days
Class 2
Risk

K153580 is an FDA 510(k) clearance for the Central Monitoring System. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Guangdong Biolight Meditech Co., Ltd. (Zhuhai, CN). The FDA issued a Cleared decision on September 7, 2016 after a review of 267 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 Guangdong Biolight Meditech Co., Ltd. devices

FDA 510(k) Submission Details - K153580

510(k) Number K153580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2015
Decision Date September 07, 2016
Days to Decision 267 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
107d slower than avg
Panel avg: 160d · This submission: 267d
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 Consultant

Mid-Link Consulting Co, Ltd.
Diana Hong

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HGM System, Monitoring, Perinatal

All 155
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K153580.
Central Monitoring System
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Meridian M110 Fetal Monitoring System
K161902 · Mindchild Medical · Jan 2017
EUM 100Pro
K150398 · Ob Tools, Ltd. · Aug 2015
Model BT-220L and BT-220C
K142799 · Bistos Co., Ltd. · Jul 2015
Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express
K150901 · Edan Instruments, Inc. · Jul 2015