Cleared Traditional

K133618 - DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM22 SERIES

K133618 is an FDA 510(k) clearance for DIGITAL AUTOMATIC WRIST BLOOD PRESSURE ..., manufactured by Grandway Technology (Shenzhen) Limited. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K133618

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
Combination Product No
PCCP Authorized No
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.

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 Peers - DXN System, Measurement, Blood-pressure, Non-invasive

All 844
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