Cleared Traditional

K871719 - MODIFIED MODEL UA-751 DIGITAL SPHYGMONO...

K871719 is the FDA 510(k) clearance for MODIFIED MODEL UA-751 DIGITAL SPHYGMONO... by A&D Engineering, Inc.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K871719 · A&D Engineering, Inc. · Cardiovascular device
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Jun 1987
Decision
32d
Days
Class 2
Risk

K871719 is an FDA 510(k) clearance for the MODIFIED MODEL UA-751 DIGITAL SPHYGMONOMETER. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by A&D Engineering, Inc. (San Jose, US). The FDA issued a Cleared decision on June 5, 1987 after a review of 32 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 A&D Engineering, Inc. devices

Submission Details

510(k) Number K871719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1987
Decision Date June 05, 1987
Days to Decision 32 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 125d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 516
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K871719.
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