Cleared Traditional

K113833 - VITAL SIGNS MONITOR

K113833 is the FDA 510(k) clearance for VITAL SIGNS MONITOR 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 126-day FDA review.

K113833 · Guangdong Biolight Meditech Co., Ltd. · Cardiovascular device
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May 2012
Decision
126d
Days
Class 2
Risk

K113833 is an FDA 510(k) clearance for the VITAL SIGNS MONITOR. 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 May 1, 2012 after a review of 126 days - within the typical 510(k) review window.

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 K113833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2011
Decision Date May 01, 2012
Days to Decision 126 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
1d slower than avg
Panel avg: 125d · This submission: 126d
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 K113833.
VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR
K132808 · Welch Allyn, Inc. · Nov 2013
VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM
K130796 · Covidien · May 2013
CONNEX VITAL SIGNS MONITOR 6000 SERIES
K121013 · Welch Allyn, Inc. · Jul 2012
CONNEX WORKSTATION
K120343 · Welch Allyn, Inc. · Feb 2012
CONNEX(R) VITAL SIGNS MONITOR 6000 SERIES
K112687 · Welch Allyn, Inc. · Nov 2011
CONNEX VITAL SIGNS MONITOR 6000 SERIES
K110516 · Welch Allyn, Inc. · Jun 2011