Cleared Traditional

K112521 - FUKUDA DENSHI VASERA MODEL VS-1500

K112521 is an FDA 510(k) clearance for FUKUDA DENSHI VASERA MODEL VS-1500, manufactured by Fukuda Denshi USA, Inc.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K112521 · Fukuda Denshi USA, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
112d
Days
Class 2
Risk

K112521 is an FDA 510(k) clearance for the FUKUDA DENSHI VASERA MODEL VS-1500. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Fukuda Denshi USA, Inc. (Redmond, US). The FDA issued a Cleared decision on December 21, 2011 after a review of 112 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.

View all Fukuda Denshi USA, Inc. devices

FDA 510(k) Submission Details - K112521

510(k) Number K112521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2011
Decision Date December 21, 2011
Days to Decision 112 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
13d faster than avg
Panel avg: 125d · This submission: 112d
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 893
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K112521.
TRYLY AUTOMATIC WRIST BLOOD PRESSURE MONITOR
K113085 · Truly Instrument Co., Ltd. · Jan 2012
U-RIGHT TD-3128 BLOOD PRESSURE MONITORING SYSTEM
K112216 · Taidoc Technology Corporation · Dec 2011
U-RIGHT TD-3135 BLOOD PRESSURE MONITORING SYSTEM
K112274 · Taidoc Technology Corporation · Dec 2011
HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS)
K110603 · I.E.M. GmbH · Dec 2011
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K111826 · Andon Health Co, Ltd. · Dec 2011
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-7902BTJ, FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MO
K111830 · Andon Health Co, Ltd. · Dec 2011