Cleared Traditional

K120554 - ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR

K120554 is an FDA 510(k) clearance for ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD ..., manufactured by Sejoy Electronics & Instruments Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K120554 · Sejoy Electronics & Instruments Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
169d
Days
Class 2
Risk

K120554 is an FDA 510(k) clearance for the ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WRIST-TYPE FULLY AUT.... Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Sejoy Electronics & Instruments Co., Ltd. (Hangzhou, Zhejiang, CN). The FDA issued a Cleared decision on August 10, 2012 after a review of 169 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 Sejoy Electronics & Instruments Co., Ltd. devices

FDA 510(k) Submission Details - K120554

510(k) Number K120554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2012
Decision Date August 10, 2012
Days to Decision 169 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
44d slower than avg
Panel avg: 125d · This submission: 169d
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 K120554.
HEM-7200-Z (BP742)
K121932 · Omron Healthcare, Inc. · Aug 2012
YA HORNG BLOOD PRESSURE MONITOR, YA HORNG BLOOD PRESSURE MONITOR, BLUETOOTH TRANSMISSION
K121025 · Ya Horng Electronic Co., Ltd. · Aug 2012
CONNECTED CARE CLINICAL APPLICATION
K120320 · Watermark Medical, Inc. · Aug 2012
DISITAL BLOOD PRESSURE MONITOR
K112620 · Nihon Seimitsu Sokki Co., Ltd. · Aug 2012
MICROLIFE WRIST WATCH BLOOD PREEURE MONITOR, BP3MO1-3P
K120430 · Microlife Intellectual Property GmbH · Aug 2012
WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
K121355 · Sejoy Electronics & Instruments Co., Ltd. · Jul 2012