Cleared Traditional

K181919 - Patient Monitor

K181919 is an FDA 510(k) clearance for Patient Monitor, 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 261-day FDA review.

K181919 · Guangdong Biolight Meditech Co., Ltd. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Apr 2019
Decision
261d
Days
Class 2
Risk

K181919 is an FDA 510(k) clearance for the Patient 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. (Zhuhai, CN). The FDA issued a Cleared decision on April 5, 2019 after a review of 261 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 - K181919

510(k) Number K181919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2018
Decision Date April 05, 2019
Days to Decision 261 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
136d slower than avg
Panel avg: 125d · This submission: 261d
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 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 - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

All 253
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