Cleared Special

K010190 - WRISTWATCH BLOOD PRESSURE MONITOR

K010190 is the FDA 510(k) clearance for WRISTWATCH BLOOD PRESSURE MONITOR by Rossmax Internationl , Ltd.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Special 510(k) pathway after a 17-day FDA review.

K010190 · Rossmax Internationl , Ltd. · Cardiovascular device
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Feb 2001
Decision
17d
Days
Class 2
Risk

K010190 is an FDA 510(k) clearance for the WRISTWATCH BLOOD PRESSURE MONITOR, MODEL A43. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Rossmax Internationl , Ltd. (Taipei, TW). The FDA issued a Cleared decision on February 8, 2001 after a review of 17 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Rossmax Internationl , Ltd. devices

Submission Details

510(k) Number K010190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2001
Decision Date February 08, 2001
Days to Decision 17 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 125d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

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
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