Cleared Special

K120634 - U-RIGHT TD-3124 BLOOD PRESSURE MONITORI...

K120634 is the FDA 510(k) clearance for U-RIGHT TD-3124 BLOOD PRESSURE MONITORI... by Taidoc Technology Corporation. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Special 510(k) pathway after a 124-day FDA review.

K120634 · Taidoc Technology Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
124d
Days
Class 2
Risk

K120634 is an FDA 510(k) clearance for the U-RIGHT TD-3124 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 July 3, 2012 after a review of 124 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.

View all Taidoc Technology Corporation devices

Submission Details

510(k) Number K120634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2012
Decision Date July 03, 2012
Days to Decision 124 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
1d faster than avg
Panel avg: 125d · This submission: 124d
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 443
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K120634.
BP652N (HEM-6300-Z)
K123498 · Omron Healthcare, Inc. · Mar 2013
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K121372 · Andon Health Co, Ltd. · Sep 2012
HEM-7200-Z (BP742)
K121932 · Omron Healthcare, Inc. · Aug 2012
FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITOR
K121470 · Andon Health Co, Ltd. · Jun 2012
KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITOR
K120672 · Andon Health Co, Ltd. · Jun 2012
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF)
K113239 · Health & Life Co., Ltd. · Mar 2012