Cleared Traditional

YA HORNG ARM TYPE DIGITAL BLOOD PRESSURE MONITOR, MODELS BP-600, BP-600R, BP-600U, BP-600B, BP-600RB, BP-600UB, BP-600J (K081590) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K081590 · Ya Horng Electronic Co., Ltd. · Cardiovascular device
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Jun 2008
Decision
13d
Days
Class 2
Risk

K081590 is an FDA 510(k) clearance for the YA HORNG ARM TYPE DIGITAL BLOOD PRESSURE MONITOR, MODELS BP-600, BP-600R, BP-.... Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Ya Horng Electronic Co., Ltd. (Nei Hu, Taipei, TW). The FDA issued a Cleared decision on June 19, 2008 after a review of 13 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 Ya Horng Electronic Co., Ltd. devices

Submission Details

510(k) Number K081590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2008
Decision Date June 19, 2008
Days to Decision 13 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 125d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 282
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