Cleared Traditional

K131941 - FETAL MONITORS

K131941 is the FDA 510(k) clearance for FETAL MONITORS by Guangdong Biolight Meditech Co., Ltd.. It is a Class 2 Obstetrics & Gynecology device (product code HGM) cleared through the Traditional 510(k) pathway after a 322-day FDA review.

K131941 · Guangdong Biolight Meditech Co., Ltd. · Obstetrics & Gynecology device
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May 2014
Decision
322d
Days
Class 2
Risk

K131941 is an FDA 510(k) clearance for the FETAL MONITORS. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Guangdong Biolight Meditech Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on May 15, 2014 after a review of 322 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: Standard predicate-based submission. Elevated predicate reliance profile. 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

Submission Details

510(k) Number K131941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2013
Decision Date May 15, 2014
Days to Decision 322 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
162d slower than avg
Panel avg: 160d · This submission: 322d
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 89
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K131941.
Central Monitoring System
K171178 · Edan Instruments, Inc. · Sep 2017
Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express
K150901 · Edan Instruments, Inc. · Jul 2015
CENTRAL MONITORING SYSTEM
K143695 · Edan Instruments, Inc. · Mar 2015
FETAL MONITORS, MODELS F2 AND F3
K102140 · Edan Instruments, Inc. · Jan 2011
CENTRAL MONITORING SYSTEM
K100358 · Edan Instruments, Inc. · Jan 2011
FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS
K100797 · Edan Instruments, Inc. · Nov 2010