Cleared Special

K112216 - U-RIGHT TD-3128 BLOOD PRESSURE MONITORING SYSTEM

K112216 is an FDA 510(k) clearance for U-RIGHT TD-3128 BLOOD PRESSURE MONITORI..., manufactured by Taidoc Technology Corporation. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Special 510(k) pathway after a 142-day FDA review.

K112216 · Taidoc Technology Corporation · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
142d
Days
Class 2
Risk

K112216 is an FDA 510(k) clearance for the U-RIGHT TD-3128 BLOOD PRESSURE MONITORING SYSTEM. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Taidoc Technology Corporation (New Taipei City, TW). The FDA issued a Cleared decision on December 22, 2011 after a review of 142 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K112216

510(k) Number K112216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2011
Decision Date December 22, 2011
Days to Decision 142 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 125d · This submission: 142d
Pathway characteristics
Modification to existing cleared device.

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

All 1126
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K112216 · U-RIGHT TD-3128 BLOOD PRESSURE MONITORING SYSTEM
Download PDF FDA Summary Taidoc Technology Cor…