Cleared Traditional

K163606 - Digital Blood Pressure Monitor-Automatic Upper Arm Style

K163606 is an FDA 510(k) clearance for Digital Blood Pressure Monitor-Automati..., manufactured by Shenzhen Combei Technology Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K163606 · Shenzhen Combei Technology Co., Ltd. · Cardiovascular device
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May 2017
Decision
139d
Days
Class 2
Risk

K163606 is an FDA 510(k) clearance for the Digital Blood Pressure Monitor-Automatic Upper Arm Style. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Shenzhen Combei Technology Co., Ltd. (Guanlan, Shenzhen, CN). The FDA issued a Cleared decision on May 9, 2017 after a review of 139 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. 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 Shenzhen Combei Technology Co., Ltd. devices

FDA 510(k) Submission Details - K163606

510(k) Number K163606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2016
Decision Date May 09, 2017
Days to Decision 139 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
14d slower than avg
Panel avg: 125d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXN Device Classification - Class 2, Special Controls

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 Consultant

Shenzhen Joyantech Consulting Co., Ltd.
Migo Yang

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.

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