Cleared Traditional

K053185 - PRIMO NONINVASIVE BLOOD PRESSURE MEASUR...

K053185 is the FDA 510(k) clearance for PRIMO NONINVASIVE BLOOD PRESSURE MEASUR... by Medwave, Inc.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K053185 · Medwave, Inc. · Cardiovascular device
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Jan 2006
Decision
71d
Days
Class 2
Risk

K053185 is an FDA 510(k) clearance for the PRIMO NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Medwave, Inc. (St. Paul, US). The FDA issued a Cleared decision on January 24, 2006 after a review of 71 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 Medwave, Inc. devices

Submission Details

510(k) Number K053185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2005
Decision Date January 24, 2006
Days to Decision 71 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
54d faster than avg
Panel avg: 125d · This submission: 71d
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 513
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K053185.
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