Cleared Traditional

K120675 - DIGITAL AUTOMATIC BLOOD PRESSURE MONITO...

K120675 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 346-day FDA review.

K120675 · Grandway Technology (Shenzhen) Limited · Cardiovascular device
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Feb 2013
Decision
346d
Days
Class 2
Risk

K120675 is an FDA 510(k) clearance for the DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM11 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 February 14, 2013 after a review of 346 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 K120675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2012
Decision Date February 14, 2013
Days to Decision 346 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
221d slower than avg
Panel avg: 125d · This submission: 346d
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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