Cleared Traditional

K171379 - Digital Automatic Wrist Blood Pressure ...

K171379 is the FDA 510(k) clearance for Digital Automatic Wrist Blood Pressure ... by Grandway Technology (Shenzhen) Limited. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 334-day FDA review.

K171379 · Grandway Technology (Shenzhen) Limited · Cardiovascular device
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Apr 2018
Decision
334d
Days
Class 2
Risk

K171379 is an FDA 510(k) clearance for the Digital Automatic Wrist Blood Pressure Monitor MD4300. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Grandway Technology (Shenzhen) Limited (Shenzhen, CN). The FDA issued a Cleared decision on April 10, 2018 after a review of 334 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Grandway Technology (Shenzhen) Limited devices

Submission Details

510(k) Number K171379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2017
Decision Date April 10, 2018
Days to Decision 334 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
209d slower than avg
Panel avg: 125d · This submission: 334d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 500
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K171379.
BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software
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Wrist Type Blood Pressure Monitor
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