Cleared Traditional

BLOOD PRESSURE MONITOR (SPHYGMOMANOMETER), MODEL HT-110 (K012194) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K012194 · Nihon Seimitsu Sokki Co., Ltd. · Cardiovascular device
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Jul 2001
Decision
7d
Days
Class 2
Risk

K012194 is an FDA 510(k) clearance for the BLOOD PRESSURE MONITOR (SPHYGMOMANOMETER), MODEL HT-110. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Nihon Seimitsu Sokki Co., Ltd. (Gunma-Ken, Tokyo, JP). The FDA issued a Cleared decision on July 20, 2001 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1120 - 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 K012194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2001
Decision Date July 20, 2001
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 DXQ Blood Pressure Cuff
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1120
Definition A Blood Pressure Cuff Is A Device That Has An Inflatable Bladder In An Elastic Sleeve (cuff) With A Mechanism For Inflating The Bladder. The Cuff Is Used To Determine A Subject's Blood Pressure.
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 - DXQ Blood Pressure Cuff

All 197
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K012194.
YP-710T Series NIBP Cuff
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