Cleared Traditional

K142088 - DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR SWBPM22 SERIES

K142088 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 91-day FDA review.

K142088 · Grandway Technology (Shenzhen) Limited · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2014
Decision
91d
Days
Class 2
Risk

K142088 is an FDA 510(k) clearance for the DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR SWBPM22 SERIES. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Grandway Technology (Shenzhen) Limited (Guang Dong, CN). The FDA issued a Cleared decision on October 31, 2014 after a review of 91 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 - K142088

510(k) Number K142088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2014
Decision Date October 31, 2014
Days to Decision 91 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
34d faster than avg
Panel avg: 125d · This submission: 91d
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 K142088.
BP652N (HEM-6300-Z)
K142917 · Omron Healthcare, Inc. · Dec 2014
AMBULO 2400 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM
K133989 · Mortara Instrument, Inc. · Nov 2014
ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
K141755 · Sejoy Electronics & Instruments Co., Ltd. · Nov 2014
BLOOD PRESSURE MONITOR
K141416 · Shenzhen Pump Medical System Co., Ltd. · Oct 2014
A&D MEDICAL UA-767F AND UA-767FAC DIGITAL BLOOD PRESSURE MONITOR
K141201 · A & D Co., Ltd. · Oct 2014
A&D MEDICAL UA-651 DIGITAL BLOOD PRESSURE MONITOR
K141160 · A & D Co., Ltd. · Oct 2014