Cleared Special

K162234 - Truscope Ultra Patient Monitor

K162234 is an FDA 510(k) clearance for Truscope Ultra Patient Monitor, manufactured by Guangdong Biolight Meditech Co., Ltd.. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Special 510(k) pathway after a 148-day FDA review.

K162234 · Guangdong Biolight Meditech Co., Ltd. · Cardiovascular device
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Jan 2017
Decision
148d
Days
Class 2
Risk

K162234 is an FDA 510(k) clearance for the Truscope Ultra 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 January 4, 2017 after a review of 148 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K162234

510(k) Number K162234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2016
Decision Date January 04, 2017
Days to Decision 148 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 125d · This submission: 148d
Pathway characteristics
Modification to existing cleared device.

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 308
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K162234 · Truscope Ultra Patient Monitor
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