Cleared Special

K200939 - Electronic Blood Pressure Monitor (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K200939 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Aug 2020
Decision
134d
Days
Class 2
Risk

K200939 is an FDA 510(k) clearance for the Electronic Blood Pressure Monitor. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. (Danyang, CN). The FDA issued a Cleared decision on August 20, 2020 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - 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.

View all Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. devices

Submission Details

510(k) Number K200939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2020
Decision Date August 20, 2020
Days to Decision 134 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 125d · This submission: 134d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
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 - DXN System, Measurement, Blood-pressure, Non-invasive

All 1209
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