Cleared Traditional

K080789 - BLOOD PRESSURE MONITOR, MODELS BP-102, BP-103, BP-201 AND BP-202

K080789 is an FDA 510(k) clearance for BLOOD PRESSURE MONITOR, 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 14-day FDA review.

K080789 · Sejoy Electronics & Instruments Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
14d
Days
Class 2
Risk

K080789 is an FDA 510(k) clearance for the BLOOD PRESSURE MONITOR, MODELS BP-102, BP-103, BP-201 AND BP-202. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Sejoy Electronics & Instruments Co., Ltd. (San Jose, US). The FDA issued a Cleared decision on April 3, 2008 after a review of 14 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.

FDA 510(k) Submission Details - K080789

510(k) Number K080789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2008
Decision Date April 03, 2008
Days to Decision 14 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 125d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Tuv Sud America, Inc.
LAURA DANIELSON

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DXN System, Measurement, Blood-pressure, Non-invasive

All 1225
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K080789.
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MQ1-2D
K080337 · Microlife Corp. · May 2008
WRIST BLOOD PRESSURE MONITOR, MODEL WS-1100/WS-1100PV
K080177 · Nihon Seimitsu Sokki Co., Ltd. · May 2008
AMBULO 2400
K080274 · Tiba Medical, Inc. · Apr 2008
CLEVER TD-3026 DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL TD-3026
K073445 · Taidoc Technology Corporation · Apr 2008
1500 PRO
K080289 · Omron Healthcare, Inc. · Feb 2008
YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-100J, BP-110J
K072860 · Ya Horng Electronic Co., Ltd. · Feb 2008
K080789 · BLOOD PRESSURE MONITOR, MODELS BP-102, BP-103, BP-201 AND BP-202
Download PDF FDA Summary Sejoy Electronics & I…