Cleared Traditional

K133618 - DIGITAL AUTOMATIC WRIST BLOOD PRESSURE ...

K133618 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 100-day FDA review.

K133618 · Grandway Technology (Shenzhen) Limited · Cardiovascular device
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Mar 2014
Decision
100d
Days
Class 2
Risk

K133618 is an FDA 510(k) clearance for the DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM22 SERIES. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Grandway Technology (Shenzhen) Limited (Shenshen, Guang Dong, CN). The FDA issued a Cleared decision on March 5, 2014 after a review of 100 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 Grandway Technology (Shenzhen) Limited devices

Submission Details

510(k) Number K133618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2013
Decision Date March 05, 2014
Days to Decision 100 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 125d · This submission: 100d
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 501
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