Cleared Traditional

K022783 - TL100 TENSMETER BLOOD PRESSURE MONITORING SYSTEM

K022783 is an FDA 510(k) clearance for TL100 TENSMETER BLOOD PRESSURE MONITORI..., manufactured by Tensys Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K022783 · Tensys Medical, Inc. · Cardiovascular device
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Nov 2002
Decision
89d
Days
Class 2
Risk

K022783 is an FDA 510(k) clearance for the TL100 TENSMETER BLOOD PRESSURE MONITORING SYSTEM. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Tensys Medical, Inc. (San Diego, US). The FDA issued a Cleared decision on November 19, 2002 after a review of 89 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 Tensys Medical, Inc. devices

FDA 510(k) Submission Details - K022783

510(k) Number K022783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2002
Decision Date November 19, 2002
Days to Decision 89 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 faster than avg
Panel avg: 125d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXN Device Classification - Class 2, Special Controls

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

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