Cleared Traditional

K152006 - Cogent Hemodynamic Monitoring System

K152006 is the FDA 510(k) clearance for Cogent Hemodynamic Monitoring System by Icu Medical, Inc.. It is a Class 2 Cardiovascular device (product code DXQ) cleared through the Traditional 510(k) pathway after a 289-day FDA review.

K152006 · Icu Medical, Inc. · Cardiovascular device
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May 2016
Decision
289d
Days
Class 2
Risk

K152006 is an FDA 510(k) clearance for the Cogent Hemodynamic Monitoring System. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Icu Medical, Inc. (San Clemente, US). The FDA issued a Cleared decision on May 5, 2016 after a review of 289 days - an extended review 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: 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 Icu Medical, Inc. devices

Submission Details

510(k) Number K152006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2015
Decision Date May 05, 2016
Days to Decision 289 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
164d slower than avg
Panel avg: 125d · This submission: 289d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 72
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K152006.
ANEROID SPHYGMOMANOMETER
K173246 · Wenzhou Bokang Instruments Co., Ltd. · May 2018
Accutension Smartphone Auscultatory Blood
K180335 · Shanghai Hulu Devices Co., Ltd. · Mar 2018
Medline Singe Patient Use Blood Pressure Cuff
K161035 · Medline Industries, Inc. · Jun 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
FLEXIPORT ECOCUFF
K122058 · Welch Allyn, Inc. · Nov 2012