Cleared Special

K073445 - CLEVER TD-3026 DIGITAL WRIST BLOOD PRES...

K073445 is the FDA 510(k) clearance for CLEVER TD-3026 DIGITAL WRIST BLOOD PRES... by Taidoc Technology Corporation. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Special 510(k) pathway after a 117-day FDA review.

K073445 · Taidoc Technology Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
117d
Days
Class 2
Risk

K073445 is an FDA 510(k) clearance for the CLEVER TD-3026 DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL TD-3026. 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 April 2, 2008 after a review of 117 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 K073445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2007
Decision Date April 02, 2008
Days to Decision 117 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 125d · This submission: 117d
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 500
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K073445.
HEM-9000AI
K081654 · Omron Healthcare, Inc. · Oct 2008
KD-391 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K080326 · Andon Health Co, Ltd. · Jul 2008
KD-591 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K080319 · Andon Health Co, Ltd. · Jul 2008
1500 PRO
K080289 · Omron Healthcare, Inc. · Feb 2008
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCHBP HOME (BP3MX1-1)
K073198 · Microlife Intellectual Property GmbH · Jan 2008
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MC1-PC
K061471 · Microlife Intellectual Property GmbH · Sep 2006