Cleared Traditional

K041789 - NONINVASIVE BLOOD PRESSURE MONITOR

K041789 is the FDA 510(k) clearance for NONINVASIVE BLOOD PRESSURE MONITOR by Meditec Co., Ltd.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K041789 · Meditec Co., Ltd. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jul 2004
Decision
13d
Days
Class 2
Risk

K041789 is an FDA 510(k) clearance for the NONINVASIVE BLOOD PRESSURE MONITOR, MODELS MD-880B AND MD-900T. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Meditec Co., Ltd. (Marietta, US). The FDA issued a Cleared decision on July 15, 2004 after a review of 13 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 Meditec Co., Ltd. devices

Submission Details

510(k) Number K041789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2004
Decision Date July 15, 2004
Days to Decision 13 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 125d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 517
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