Cleared Traditional

K092106 - U-RIGHT TD-3132 BLOOD PRESSURE MONITOR

K092106 is the FDA 510(k) clearance for U-RIGHT TD-3132 BLOOD PRESSURE MONITOR by Taidoc Technology Corporation. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K092106 · Taidoc Technology Corporation · Cardiovascular device
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Jan 2010
Decision
195d
Days
Class 2
Risk

K092106 is an FDA 510(k) clearance for the U-RIGHT TD-3132 BLOOD PRESSURE MONITOR, FORA P 20 BLOOD PRESSURE MONITOR, MOD.... 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 January 25, 2010 after a review of 195 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Taidoc Technology Corporation devices

Submission Details

510(k) Number K092106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2009
Decision Date January 25, 2010
Days to Decision 195 days
Submission Type Traditional
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
70d slower than avg
Panel avg: 125d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 492
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K092106.
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K093823 · Health & Life Co., Ltd. · Jan 2010
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7035B, KD-7921, KD-7903
K092811 · Andon Health Co, Ltd. · Jan 2010
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5910,KD-5911, KD-5918
K092588 · Andon Health Co, Ltd. · Dec 2009