Cleared Traditional

K911049 - DIGITAL SPHYGMOIMANOMETER

K911049 is the FDA 510(k) clearance for DIGITAL SPHYGMOIMANOMETER by A&D Engineering, Inc.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K911049 · A&D Engineering, Inc. · Cardiovascular device
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Aug 1991
Decision
152d
Days
Class 2
Risk

K911049 is an FDA 510(k) clearance for the DIGITAL SPHYGMOIMANOMETER, MODEL UA-830. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by A&D Engineering, Inc. (Milpitas, US). The FDA issued a Cleared decision on August 7, 1991 after a review of 152 days - an extended review 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: 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 A&D Engineering, Inc. devices

Submission Details

510(k) Number K911049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1991
Decision Date August 07, 1991
Days to Decision 152 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 125d · This submission: 152d
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 526
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K911049.
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K913523 · Omron Healthcare, Inc. · Nov 1991
DIGITAL SPHYGMOMANOMETER MODEL UA-833
K912118 · A&D Engineering, Inc. · Aug 1991
DIGITAL SPHYGMOMANOMETER MODEL UB-211 AND 212
K912119 · A&D Engineering, Inc. · Aug 1991
CARDIOCAP CMX-104 MONITOR
K903237 · Datex Division Instrumentarium Corp. · Jul 1991