Cleared Traditional

K132240 - DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM06 SERIES

K132240 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 151-day FDA review.

K132240 · Grandway Technology (Shenzhen) Limited · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K132240

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
Combination Product No
PCCP Authorized No
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.

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 K132240.
OREGON SCINTIFIC
K131245 · Idt Technology Limited · Jan 2014
HEM-7311
K133379 · Omron Healthcare, Inc. · Jan 2014
ARM AUTOMATIC BLOOD PRESSURE MONITOR
K130325 · Shenzhen Pump Medical System Co., Ltd. · Dec 2013
BOSCH BLOOD PRESSURE METER (BP5000 BT)
K131026 · Robert Bosch Healthcare Systems, Inc. · Nov 2013
AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
K132627 · Honsun (Nantong) Co., Ltd. · Oct 2013
HEM-6221
K131749 · Omron Healthcare, Inc. · Oct 2013