Cleared Traditional

K072860 - YA HORNG DIGITAL UPPER ARM BLOOD PRESSU...

Also marketed or referenced as:
DIGITAL WRIST BLOOD PRESSURE MONITOR, BP-500,BP-500

K072860 is an FDA 510(k) clearance for YA HORNG DIGITAL UPPER ARM BLOOD PRESSU..., manufactured by Ya Horng Electronic Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K072860 · Ya Horng Electronic Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
143d
Days
Class 2
Risk

K072860 is an FDA 510(k) clearance for the YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-100J, BP-110J. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Ya Horng Electronic Co., Ltd. (Hsin-Chu City, TW). The FDA issued a Cleared decision on February 25, 2008 after a review of 143 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 Ya Horng Electronic Co., Ltd. devices

FDA 510(k) Submission Details - K072860

510(k) Number K072860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2007
Decision Date February 25, 2008
Days to Decision 143 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
18d slower than avg
Panel avg: 125d · This submission: 143d
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 567
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K072860.
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