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
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 88
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K143332.
Medline Singe Patient Use Blood Pressure Cuff
K161035 · Medline Industries, Inc. · Jun 2016
Cogent Hemodynamic Monitoring System
K152006 · Icu Medical, Inc. · May 2016
Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra long), Value Care Cuff Adult, Value Care Cuff Small Adult, Value Care Cuff Pediatric, Value Care Cuff Infant, Efficia Adult NIBP Airhose, 3 M, Efficia Adult NIBP Air Hose, 1.5 M
K152363 · Philips Medical Systems · Oct 2015
ANDON BLOOD PRESSURE CUFF
K133117 · Andon Health Co, Ltd. · Mar 2014
RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFF
K123996 · Ge Medical Systems Information Technologies, Inc. · Apr 2013
FLEXIPORT ECOCUFF
K122058 · Welch Allyn, Inc. · Nov 2012