Cleared Traditional

K022926 - GENTEEL WRIST DIGITAL BLOOD PRESSURE MO...

K022926 is the FDA 510(k) clearance for GENTEEL WRIST DIGITAL BLOOD PRESSURE MO... by Genteel Technology Co., Ltd.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 306-day FDA review.

K022926 · Genteel Technology Co., Ltd. · Cardiovascular device
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Jun 2003
Decision
306d
Days
Class 2
Risk

K022926 is an FDA 510(k) clearance for the GENTEEL WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL BP-100. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Genteel Technology Co., Ltd. (Flagstaff, US). The FDA issued a Cleared decision on June 6, 2003 after a review of 306 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Genteel Technology Co., Ltd. devices

Submission Details

510(k) Number K022926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2002
Decision Date June 06, 2003
Days to Decision 306 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
181d slower than avg
Panel avg: 125d · This submission: 306d
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

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