Cleared Traditional

K131898 - A SERIES AND Q SERIES PATIENT MONITORS

K131898 is the FDA 510(k) clearance for A SERIES AND Q SERIES PATIENT MONITORS by Guangdong Biolight Meditech Co., Ltd.. It is a Class 2 Cardiovascular device (product code MWI) cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K131898 · Guangdong Biolight Meditech Co., Ltd. · Cardiovascular device
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Feb 2014
Decision
238d
Days
Class 2
Risk

K131898 is an FDA 510(k) clearance for the A SERIES AND Q SERIES PATIENT MONITORS. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Guangdong Biolight Meditech Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on February 18, 2014 after a review of 238 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - the FDA cardiovascular device oversight 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 Cardiovascular 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 K131898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2013
Decision Date February 18, 2014
Days to Decision 238 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d slower than avg
Panel avg: 125d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

All 124
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K131898.
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