Cleared Traditional

K091414 - VTRUST BLOOD PRESSURE MONITOR

K091414 is the FDA 510(k) clearance for VTRUST BLOOD PRESSURE MONITOR by Biocare Corp.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K091414 · Biocare Corp. · Cardiovascular device
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Oct 2009
Decision
161d
Days
Class 2
Risk

K091414 is an FDA 510(k) clearance for the VTRUST BLOOD PRESSURE MONITOR, MODEL VTRUST 701DH. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Biocare Corp. (Taoyuan, TW). The FDA issued a Cleared decision on October 21, 2009 after a review of 161 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 Biocare Corp. devices

Submission Details

510(k) Number K091414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2009
Decision Date October 21, 2009
Days to Decision 161 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
36d slower than avg
Panel avg: 125d · This submission: 161d
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 504
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K091414.
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