Cleared Traditional

K120675 - DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM11 SERIES

K120675 is an FDA 510(k) clearance for DIGITAL AUTOMATIC BLOOD PRESSURE MONITO..., 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 346-day FDA review.

K120675 · Grandway Technology (Shenzhen) Limited · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K120675

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
Combination Product No
PCCP Authorized No
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.

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
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K120675.
DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM03 SERIES MODEL MD03X0
K123073 · Grandway Technology (Shenzhen) Limited · Mar 2013
TRANSTEK BLOOD PRESSURE MONITOR
K123780 · Zhongshan Transtek Electronics Co., Ltd. · Mar 2013
DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM15 SERIES
K120673 · Grandway Technology (Shenzhen) Limited · Feb 2013
COMPACT DIGITAL BLOOD PRESSURE MONITOR
K122810 · Thermor , Ltd. · Feb 2013
WA SERIES: WA100
K123839 · Ningbo Diaier Electronic Co., Ltd. · Jan 2013
TRANSTEK WRIST BLOOD PRESSURE MONITOR
K123669 · Zhongshan Transtek Electronics Co., Ltd. · Dec 2012