Cleared Traditional

K120193 - ANY VIEW PATIENT MONITORS

K120193 is an FDA 510(k) clearance for ANY VIEW PATIENT MONITORS, manufactured by Guangdong Biolight Meditech Co., Ltd.. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K120193 · Guangdong Biolight Meditech Co., Ltd. · Cardiovascular device
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Jun 2012
Decision
158d
Days
Class 2
Risk

K120193 is an FDA 510(k) clearance for the ANY VIEW 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 June 29, 2012 after a review of 158 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

FDA 510(k) Submission Details - K120193

510(k) Number K120193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2012
Decision Date June 29, 2012
Days to Decision 158 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 125d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MWI Device Classification - Class 2, Special Controls

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 253
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K120193.
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DATACAPTOR SYSTEM
K113835 · Capsule Tech, Inc. · Jun 2012
EXPRESSION INFORMATION PORTAL
K121424 · Invivo Corporation · Jun 2012
VITAL SIGNS MONITOR
K113833 · Guangdong Biolight Meditech Co., Ltd. · May 2012