Cleared Traditional

K993316 - UEDA UDEX SUPER BP-2000 AUTOMATIC BLOOD...

K993316 is the FDA 510(k) clearance for UEDA UDEX SUPER BP-2000 AUTOMATIC BLOOD... by Ueda Avancer Corp.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K993316 · Ueda Avancer Corp. · Cardiovascular device
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Jun 2000
Decision
249d
Days
Class 2
Risk

K993316 is an FDA 510(k) clearance for the UEDA UDEX SUPER BP-2000 AUTOMATIC BLOOD PRESSURE RECORDING DEVICE. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Ueda Avancer Corp. (Crofton, US). The FDA issued a Cleared decision on June 9, 2000 after a review of 249 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 Ueda Avancer Corp. devices

Submission Details

510(k) Number K993316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1999
Decision Date June 09, 2000
Days to Decision 249 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 125d · This submission: 249d
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 520
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K993316.
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