Cleared Traditional

K121355 - WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR

K121355 is an FDA 510(k) clearance for WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOO..., 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 75-day FDA review.

K121355 · Sejoy Electronics & Instruments Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
75d
Days
Class 2
Risk

K121355 is an FDA 510(k) clearance for the WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR. 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 July 18, 2012 after a review of 75 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sejoy Electronics & Instruments Co., Ltd. devices

FDA 510(k) Submission Details - K121355

510(k) Number K121355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2012
Decision Date July 18, 2012
Days to Decision 75 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
50d faster than avg
Panel avg: 125d · This submission: 75d
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 K121355.
ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
K120554 · Sejoy Electronics & Instruments Co., Ltd. · 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
U-RIGHT TD-3124 BLOOD PRESSURE MONITORING SYSTEM
K120634 · Taidoc Technology Corporation · Jul 2012
FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITOR
K121470 · Andon Health Co, Ltd. · Jun 2012
KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITOR
K120672 · Andon Health Co, Ltd. · Jun 2012