Cleared Traditional

K132240 - DIGITAL AUTOMATIC BLOOD PRESSURE MONITO...

K132240 is the FDA 510(k) clearance for DIGITAL AUTOMATIC BLOOD PRESSURE MONITO... by Grandway Technology (Shenzhen) Limited. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K132240 · Grandway Technology (Shenzhen) Limited · Cardiovascular device
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Dec 2013
Decision
151d
Days
Class 2
Risk

K132240 is an FDA 510(k) clearance for the DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM06 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 December 16, 2013 after a review of 151 days - an extended review cycle.

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 K132240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2013
Decision Date December 16, 2013
Days to Decision 151 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
26d slower than avg
Panel avg: 125d · This submission: 151d
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

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