Cleared Traditional

K050697 - MODEL DS-1901 DIGITAL BLOOD PRESSURE MO...

K050697 is the FDA 510(k) clearance for MODEL DS-1901 DIGITAL BLOOD PRESSURE MO... by Nihon Seimitsu Sokki Co., Ltd.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K050697 · Nihon Seimitsu Sokki Co., Ltd. · Cardiovascular device
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Mar 2005
Decision
7d
Days
Class 2
Risk

K050697 is an FDA 510(k) clearance for the MODEL DS-1901 DIGITAL BLOOD PRESSURE MONITOR. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Nihon Seimitsu Sokki Co., Ltd. (Flemington, US). The FDA issued a Cleared decision on March 25, 2005 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 Nihon Seimitsu Sokki Co., Ltd. devices

Submission Details

510(k) Number K050697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2005
Decision Date March 25, 2005
Days to Decision 7 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
118d faster than avg
Panel avg: 125d · This submission: 7d
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 503
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K050697.
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FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168ET
K043437 · Health & Life Co., Ltd. · Jan 2005
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K043186 · Health & Life Co., Ltd. · Dec 2004
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K042853 · Health & Life Co., Ltd. · Nov 2004