Cleared Traditional

K012636 - BPTRU AUTOMATED NON-INVASIVE BLOOD PRES...

K012636 is the FDA 510(k) clearance for BPTRU AUTOMATED NON-INVASIVE BLOOD PRES... by Vsm Technology, Inc.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K012636 · Vsm Technology, Inc. · Cardiovascular device
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Oct 2001
Decision
74d
Days
Class 2
Risk

K012636 is an FDA 510(k) clearance for the BPTRU AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Vsm Technology, Inc. (Vancouver, B.C., CA). The FDA issued a Cleared decision on October 26, 2001 after a review of 74 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 Vsm Technology, Inc. devices

Submission Details

510(k) Number K012636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2001
Decision Date October 26, 2001
Days to Decision 74 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
51d faster than avg
Panel avg: 125d · This submission: 74d
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 517
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K012636.
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