Cleared Traditional

K143332 - Fast Sphyg by Koven

K143332 is an FDA 510(k) clearance for Fast Sphyg by Koven, manufactured by Koven Technology, Inc.. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K143332 · Koven Technology, Inc. · Cardiovascular device
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Apr 2015
Decision
145d
Days
Class 2
Risk

K143332 is an FDA 510(k) clearance for the Fast Sphyg by Koven. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Koven Technology, Inc. (St Louis, US). The FDA issued a Cleared decision on April 14, 2015 after a review of 145 days - within the typical 510(k) review window.

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: 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 Koven Technology, Inc. devices

FDA 510(k) Submission Details - K143332

510(k) Number K143332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2014
Decision Date April 14, 2015
Days to Decision 145 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
20d slower than avg
Panel avg: 125d · This submission: 145d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXQ Device Classification - Class 2, Special Controls

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 160
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K143332.
Aneroid Sphygmomanometer
K151246 · Jiaxing Zhongfa Medical Products Co., Ltd. · Jun 2015
Disposable Blood Pressure Cuff, Reusable Blood Pressure Cuff
K151290 · Xuzhou Maicuff Technology Co., Ltd. · Jun 2015
Minhua Disposable Blood Pressure Cuff
K143728 · Suzhou Minhua Medical Apparatus · May 2015
Disposable Blood Pressure Cuff Guard
K150227 · Pinhu Sama Medical Packing Co., Ltd. · Apr 2015
SAMA DISPOSABLE BLOOD PRESSURE CUFF BARRIERS
K141998 · Pinghu Sama Medical Packing Co., Ltd. · Sep 2014
GH DISPOSABLE AND GH REUSABLE BLOOD PRESSURE CUFF
K140874 · Shanghai Goahui Rubber and Plastic Company · Sep 2014