Cleared Traditional

K041228 - MYTECH/HAPPY LIFE BLOOD PRESSURE MONITOR, MODEL HPL-200

K041228 is an FDA 510(k) clearance for MYTECH/HAPPY LIFE BLOOD PRESSURE MONITOR, manufactured by Mytech Technology Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K041228 · Mytech Technology Co., Ltd. · Cardiovascular device
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May 2004
Decision
7d
Days
Class 2
Risk

K041228 is an FDA 510(k) clearance for the MYTECH/HAPPY LIFE BLOOD PRESSURE MONITOR, MODEL HPL-200. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Mytech Technology Co., Ltd. (Hsin-Chu City, TW). The FDA issued a Cleared decision on May 17, 2004 after a review of 7 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. 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 Mytech Technology Co., Ltd. devices

FDA 510(k) Submission Details - K041228

510(k) Number K041228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2004
Decision Date May 17, 2004
Days to Decision 7 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
118d faster than avg
Panel avg: 125d · This submission: 7d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXN Device Classification - Class 2, Special Controls

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 750
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