Submission Details
| 510(k) Number | K152006 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Cogent Hemodynamic Monitoring System
May 2016
Decision
289d
Days
Class 2
Risk
About This 510(k) Submission
K152006 is an FDA 510(k) clearance for the Cogent Hemodynamic Monitoring System, a Blood Pressure Cuff (Class II — Special Controls, product code DXQ), submitted by Icu Medical, Inc. (San Clemente, US). The FDA issued a Cleared decision on May 5, 2016, 289 days after receiving the submission on July 21, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1120.
Device Classification
| Product Code | DXQ — Blood Pressure Cuff |
| Device Class | Class II — 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. |
Manufacturer
Similar Devices — DXQ Blood Pressure Cuff
All 196
K253089 · Shenzhen Best Electronics Co., Ltd.
· Feb 2026
K253964 · Unimed Medical Supplies, Inc.
· Jan 2026
K251745 · Baxter Healthcare Corporation
· Dec 2025
K250765 · Avita Corporation
· Sep 2025
K251045 · Unimed Medical Supplies, Inc.
· Jul 2025
K242623 · Shenzhen Medke Technology Co., Ltd.
· Oct 2024
More from Icu Medical, Inc.
View all
K250616
· FPA · Jun 2025
K242114
· FRN · Apr 2025
K242115
· FRN · Apr 2025
K242117
· PHC · Apr 2025
K243985
· LHI · Jan 2025