Cleared Special

K091897 - BLOOD PRESSURE MONITOR

K091897 is the FDA 510(k) clearance for BLOOD PRESSURE MONITOR by Taidoc Technology Corporation. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Special 510(k) pathway after a 62-day FDA review.

K091897 · Taidoc Technology Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
62d
Days
Class 2
Risk

K091897 is an FDA 510(k) clearance for the BLOOD PRESSURE MONITOR, MODEL FORA P11/TD-3019. 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 August 25, 2009 after a review of 62 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. 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 K091897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2009
Decision Date August 25, 2009
Days to Decision 62 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
63d faster than avg
Panel avg: 125d · This submission: 62d
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 K091897.
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168KB
K092163 · Health & Life Co., Ltd. · Nov 2009
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3BS1-3C
K092456 · Microlife Intellectual Property GmbH · Oct 2009
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868BF
K092161 · Health & Life Co., Ltd. · Sep 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-5917, KD-5915, KD-5031
K091737 · Andon Health Co, Ltd. · Aug 2009
SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-388BD
K091738 · Andon Health Co, Ltd. · Aug 2009
SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-3917, KD 3909
K091739 · Andon Health Co, Ltd. · Aug 2009