Cleared Traditional

K080177 - WRIST BLOOD PRESSURE MONITOR, MODEL WS-1100/WS-1100PV

K080177 is an FDA 510(k) clearance for WRIST BLOOD PRESSURE MONITOR, manufactured by Nihon Seimitsu Sokki Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K080177 · Nihon Seimitsu Sokki Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
106d
Days
Class 2
Risk

K080177 is an FDA 510(k) clearance for the WRIST BLOOD PRESSURE MONITOR, MODEL WS-1100/WS-1100PV. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Nihon Seimitsu Sokki Co., Ltd. (Tachikawa-Shi, Tokyo, JP). The FDA issued a Cleared decision on May 9, 2008 after a review of 106 days - within the typical 510(k) review window.

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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K080177

510(k) Number K080177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2008
Decision Date May 09, 2008
Days to Decision 106 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 125d · This submission: 106d
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 1207
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K080177.
KD-591 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
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AMBULO 2400
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K080789 · Sejoy Electronics & Instruments Co., Ltd. · Apr 2008
CLEVER TD-3026 DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL TD-3026
K073445 · Taidoc Technology Corporation · Apr 2008
K080177 · WRIST BLOOD PRESSURE MONITOR, MODEL WS-1100/WS-1100PV
Download PDF FDA Summary Nihon Seimitsu Sokki …