Panels › Cardiovascular › Product code DRY · Class 2
Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Regulation 870.4330
0510(k)s in 12 months (47 all time)
0recalls in 12 months (40 all time)
37recalls that name a 510(k)
Top companies in DRY
| Company | 510(k)s | Recalls |
|---|---|---|
| Terumo Cardiovascular Systems Corp. | 4 | 38 |
| Spectrum Medical , Ltd. | 7 | 0 |
| 3M Company | 3 | 0 |
| 3M Healthcare | 2 | 0 |
| Cardiovascular Devices, Inc. | 2 | 0 |
| International Biophysics Corp. | 2 | 0 |
| Spectrum Medical, Llp | 2 | 0 |
| 3M Health Care, Ltd. | 1 | 0 |
| American Bentley | 1 | 0 |
| Bentley Laboratories, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 24, 2025 | Terumo Cardiovascular Systems Corporation CDI OneView System BPM Probe:
Cat. No. CDI753 - CDI OneView BPM Probe,
Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit Open, Classified |
DRY | K234065 |
| Mar 31, 2025 | Terumo Cardiovascular Systems Corporation Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754 Open, Classified |
DRY | K234065 |
| Sep 30, 2020 | Maquet Cardiovascular Us Sales, Llc Blood Monitoring Unit (BMU 40), model no. 701040852 - Product Usage: is to monitor blood parameters during cardiopulmonary bypass (CPB) or similar procedures with extracorporeal circulation, which req Terminated |
DRY | K090147 |
| Jun 26, 2018 | Terumo Cardiovascular Systems Corporation Monitor with one Blood Parameter Module and one HSat Probe; 500AHCT
Monitor with two Blood Parameter modules and one HSat Probe; 500AVHCT
Product Usage:
The CDI System 500 provides continuous, on-lin Terminated |
DRY | K133658 |
| Jun 26, 2018 | Terumo Cardiovascular Systems Corporation CDI Blood parameter monitoring system 500 H/SAT, Part No. 145883
Product Usage:
The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon Terminated |
DRY | K133658 |
| Mar 25, 2016 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System 500
Cardiopulmonary bypass on-line blood gas monitor
Product Usage:
The CDL System 500 provides continuous, on-line monitoring of the extracorporeal partial pre Terminated |
DRY | K133658 |
| Dec 11, 2015 | Terumo Cardiovascular Systems Corporation CDI H/S Cuvette
The intended use for the CDI H IS Cuvette is as follows: The CDI H/S Cuvettes are intended for use with a CDI monitor during cardiopulmonary bypass procedures when continuous monitori Terminated |
DRY | K915265 |
| Sep 9, 2015 | Terumo Cardiovascular Systems Corporation CDI 500 Blood Parameter Monitoring System.
Provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and and carbon dioxide, pH, potassium, oxygen saturation, hematocrit Terminated |
DRY | K133658 |
| May 19, 2014 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System; Catalog Numbers or Part Numbers - 145891, 500AVHCT; Serial Numbers - BPM SN B015552 (installed into CDI 500 Monitor SN 3535) Terminated |
DRY | K972962 |
| Jul 13, 2013 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System 500 with Venous blood parameter module.
Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, Terminated |
DRY | K972962 |
| Jul 13, 2013 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module.
Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2 Terminated |
DRY | K972962 |
| Jul 13, 2013 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules.
Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or veno Terminated |
DRY | K972962 |
| Jul 13, 2013 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modules and Hematocrit/Saturation probe.
Intended for use during cardiopulmonary bypass procedures when continuous monitoring Terminated |
DRY | K972962 |
| Jul 13, 2013 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe.
Intended for use during cardiopulmonary bypass procedures when continuous m Terminated |
DRY | K972962 |
| Feb 12, 2013 | Terumo Cardiovascular Systems Corporation Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood/oxygen saturation, hematocrit and hemoglobin levels. Terminated |
DRY | None listed |
| Apr 6, 2012 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System 500, 500V.
Intended for use during cardiopulmonary bypass procedures. Terminated |
DRY | K972962 |
| Apr 6, 2012 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System 500, 500A.
Intended for use during cardiopulmonary bypass procedures. Terminated |
DRY | K972962 |
| Apr 6, 2012 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System 500, 500AV.
Intended for use during cardiopulmonary bypass procedures. Terminated |
DRY | K972962 |
| Apr 6, 2012 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System 500, 500AHCT.
Intended for use during cardiopulmonary bypass procedures. Terminated |
DRY | K972962 |
| Apr 6, 2012 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System 500, 500AVHCT.
Intended for use during cardiopulmonary bypass procedures. Terminated |
DRY | K972962 |
| Jan 11, 2012 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System 500
Product Usage: The CDl Blood Parameter Monitoring System 500 is intended for use during cardiopulmonary bypass procedures when continuous monitoring of arte Terminated |
DRY | K972962 |
| Jan 11, 2012 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System 500
Product Usage: The CDl Blood Parameter Monitoring System 500 is intended for use during cardiopulmonary bypass procedures when continuous monitoring of arte Terminated |
DRY | K972962 |
| Jan 11, 2012 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System 500
Product Usage: The CDl Blood Parameter Monitoring System 500 is intended for use during cardiopulmonary bypass procedures when continuous monitoring of arte Terminated |
DRY | K972962 |
| Jan 11, 2012 | Terumo Cardiovascular Systems Corporation CDI 101 Hematocrit/Oxygen Saturation Monitoring System. The CDI 101 Hematocrit/Oxygen Saturation Monitoring System is intended for use during cardiopulmonary bypass procedures where continuous monitor Terminated |
DRY | None listed |
| Jan 11, 2012 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System 500
Product Usage: The CDl Blood Parameter Monitoring System 500 is intended for use during cardiopulmonary bypass procedures when continuous monitoring of arte Terminated |
DRY | K972962 |
| Oct 31, 2011 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System 500 including all Catalog Numbers to include: Catalog # 500AVHCT with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe.
Catalog Numbe Terminated |
DRY | K972962 |
| Jun 28, 2011 | Terumo Cardiovascular Systems Corporation Terumo Cardiovascular Systems, CDI 100 Hematocrit/Oxygen saturation monitoring system, catalog 100. Terminated |
DRY | K902654 |
| Jun 28, 2011 | Terumo Cardiovascular Systems Corporation Terumo Cardiovascular Systems, CDI 101 Hematocrit/Oxygen saturation monitoring system, catalog 101. Terminated |
DRY | K902654 |
| Jun 28, 2011 | Terumo Cardiovascular Systems Corporation Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with venous blood parameter module, catalog 500V. Terminated |
DRY | K972962 |
| Jun 28, 2011 | Terumo Cardiovascular Systems Corporation Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with arterial blood parameter module, catalog 500A. Terminated |
DRY | K972962 |
| Jun 28, 2011 | Terumo Cardiovascular Systems Corporation Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with arterial and venous blood parameter modules, catalog 500AV. Terminated |
DRY | K972962 |
| Jun 28, 2011 | Terumo Cardiovascular Systems Corporation Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with arterial blood parameter module and hematocrit/saturation probe, catalog 500AHCT. Terminated |
DRY | K972962 |
| Jun 28, 2011 | Terumo Cardiovascular Systems Corporation Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe, Catalog AVHCT. Terminated |
DRY | K972962 |
| Jun 22, 2011 | Terumo Cardiovascular Systems Corporation CDI TM 101 Monitor, CDI TM 101 Hematocrit/Oxygen Saturation Monitoring System,
The CDI TM 101 Hematocrit/Oxygen Saturation Monitoring System is intended for use during cardiopulmonary bypass procedu Terminated |
DRY | K902654 |
| May 12, 2011 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System 500 with Venous Blood parameter module Catalog number 500V , Terumo Cardiovascular Systems Corporations, Ann Arbor, MI.
The CDI 500 is indicated for use Terminated |
DRY | K972962 |
| May 12, 2011 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System 500 with Arterial Blood parameter module Catalog number 500A , Terumo Cardiovascular Systems Corporations, Ann Arbor, MI.
The CDI 500 is indicated for use Terminated |
DRY | K972962 |
| May 12, 2011 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules, Catalog 500AV, Terumo Cardiovascular Systems
The CDI 500 is indicated for use to display patient blood gas Terminated |
DRY | K972962 |
| May 12, 2011 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module and Hematocrit/Saturation probe, Catalog 500AHCT, Terumo Cardiovascular Systems Corporations, Ann Arbor, MI.
The CDI 50 Terminated |
DRY | K972962 |
| May 12, 2011 | Terumo Cardiovascular Systems Corporation CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe, Catalog 500AVHCT, Terumo Cardiovascular Systems Corporations, Ann Arbor, MI. Terminated |
DRY | K972962 |
| Jul 30, 2008 | Medtronic International Trade Inc Medtronic Trillium AFFINITY NT, 511T, Hollow Fiber Oxygenator with Trillium Biopassive Surface, with Plasma Resistant Fiber. MODEL Numbers: 95215, 95216, 95217, 95249, 95250, 95252, 0H46R28, 0M81R4 Terminated |
DRY | None listed |
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