Cleared Traditional

K061073 - CLEVER CHECK TD-3250 BLOOD GLUCOSE AND ...

K061073 is the FDA 510(k) clearance for CLEVER CHECK TD-3250 BLOOD GLUCOSE AND ... by Taidoc Technology Corporation. It is a Class 2 Chemistry device (product code DXN) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K061073 · Taidoc Technology Corporation · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
46d
Days
Class 2
Risk

K061073 is an FDA 510(k) clearance for the CLEVER CHECK TD-3250 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMENT SYSTEM, MOD.... Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Taidoc Technology Corporation (San Chung, Taipei, TW). The FDA issued a Cleared decision on June 2, 2006 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 870.1130 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Taidoc Technology Corporation devices

Submission Details

510(k) Number K061073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2006
Decision Date June 02, 2006
Days to Decision 46 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 88d · This submission: 46d
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 Chemistry devices follow this clearance model.

Regulatory Peers - DXN System, Measurement, Blood-pressure, Non-invasive

All 507
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K061073.
A & D MEDICAL UM-101 DIGITAL BLOOD PRESSURE MONITOR
K061456 · A&D Engineering, Inc. · Jun 2006
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1-4U
K061403 · Microlife Intellectual Property GmbH · Jun 2006
MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP3AC1-1PC
K060686 · Microlife Intellectual Property GmbH · Jun 2006
ACON AUTOMATIC BLOOD PRESSURE MONITOR KIT, MODEL OB11-111, W/AC ADAPTER, MODEL OB11-112
K060925 · ACON Laboratories, Inc. · May 2006
HL888SF
K060835 · Health & Life Co., Ltd. · Apr 2006
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168FV
K060729 · Health & Life Co., Ltd. · Apr 2006