Cleared Special

TL-200 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM (K121141) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K121141 · Tensys Medical Systems, Inc. · Cardiovascular device
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May 2012
Decision
29d
Days
Class 2
Risk

K121141 is an FDA 510(k) clearance for the TL-200 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Tensys Medical Systems, Inc. (San Diego, US). The FDA issued a Cleared decision on May 15, 2012 after a review of 29 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 Tensys Medical Systems, Inc. devices

Submission Details

510(k) Number K121141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2012
Decision Date May 15, 2012
Days to Decision 29 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
96d faster than avg
Panel avg: 125d · This submission: 29d
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 1213
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