Cleared Traditional

K112620 - DISITAL BLOOD PRESSURE MONITOR

K112620 is an FDA 510(k) clearance for DISITAL 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 329-day FDA review.

K112620 · Nihon Seimitsu Sokki Co., Ltd. · Cardiovascular device
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Aug 2012
Decision
329d
Days
Class 2
Risk

K112620 is an FDA 510(k) clearance for the DISITAL 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. (Bunkyo-Ku, Tokyo, JP). The FDA issued a Cleared decision on August 2, 2012 after a review of 329 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Nihon Seimitsu Sokki Co., Ltd. devices

FDA 510(k) Submission Details - K112620

510(k) Number K112620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2011
Decision Date August 02, 2012
Days to Decision 329 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
204d slower than avg
Panel avg: 125d · This submission: 329d
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 844
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K112620.
YA HORNG BLOOD PRESSURE MONITOR, YA HORNG BLOOD PRESSURE MONITOR, BLUETOOTH TRANSMISSION
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