DRY · Class II · 21 CFR 870.4330

FDA Product Code DRY: Monitor, Blood-gas, On-line, Cardiopulmonary Bypass

Leading manufacturers include Spectrum Medical , Ltd., 3M Company and Terumo Cardiovascular Systems Corporation.

47
Total
47
Cleared
97d
Avg days
1981
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Monitor, Blood-gas, On-line, Cardiopulmonary Bypass Devices (Product Code DRY)

47 devices
1–24 of 47
Cleared Apr 25, 2024
CDI OneView Monitoring System
K234065
Terumo Cardiovascular Systems Corporation
Cardiovascular · 125d
Cleared Apr 01, 2021
B-Capta
K202154
Livanova Deutschland, GmbH
Cardiovascular · 241d
Cleared Oct 02, 2020
Quantum Workstation 12 Elite
K202557
Spectrum Medical , Ltd.
Cardiovascular · 29d
Cleared Nov 02, 2018
CDI Blood Parameter Monitoring System 550
K182110
Terumo Cardiovascular Systems Corporation
Cardiovascular · 88d
Cleared Aug 17, 2018
Quantum Workstation 12.1
K181923
Spectrum Medical , Ltd.
Cardiovascular · 30d
Cleared Mar 28, 2018
Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas
K173591
Spectrum Medical , Ltd.
Cardiovascular · 127d
Cleared Jan 18, 2017
Quantum Workstation
K163657
Spectrum Medical , Ltd.
Cardiovascular · 26d
Cleared Oct 23, 2014
TRI-OPTIC MEASUREMENT CELL
K133157
Medtronic, Inc.
Cardiovascular · 371d
Cleared Jul 25, 2014
CDI BLOOD PARAMETER MONITORING SYSTEM 500
K133658
Terumo Cardiovascular Systems Corp.
Cardiovascular · 240d
Cleared Nov 20, 2012
CDI BLOOD PARAMETER MONITORING SYSTEM 500
K123039
Terumo Cardiovascular Systems Corp.
Cardiovascular · 53d
Cleared May 31, 2011
M4 MONITOR
K110957
Spectrum Medical, Llp
Cardiovascular · 56d
Cleared Jan 06, 2011
B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD)
K103168
Sorin Group Deutschland GmbH
Cardiovascular · 71d
Cleared Apr 22, 2009
BLOOD MONITORING UNIT, MODEL BMU 40
K090147
Maquet Cardiopulmonary, AG
Cardiovascular · 91d
Cleared Sep 14, 2001
TRILLIUM TRI-OPTIC MEASUREMENT CELL, MODEL TMC 25T, TMC38 T, TMC 50T
K012743
Medtronic Perfusion Systems
Cardiovascular · 29d
Cleared May 15, 1998
3M CDI QUICK-CELLS WITH HEPARIN TREATMENT
K980732
3M Healthcare
Cardiovascular · 79d
Cleared Dec 08, 1997
3M CDI H/S CUVETTES WITH HEPARON TREATMENT
K973472
3M Healthcare
Cardiovascular · 87d
Cleared Nov 06, 1997
3M CDI BLOOD PARAMETER MONITORING SYSTEM 500
K972962
3M Company
Cardiovascular · 87d
Cleared May 14, 1996
IBC GAS CELL COMPONENTS (1/2, 3/8, 1/4)
K955379
International Biophysics Corp.
Cardiovascular · 172d
Cleared May 14, 1996
IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4)
K955380
International Biophysics Corp.
Cardiovascular · 172d
Cleared Nov 10, 1993
CDI 100 EXTRACORPOREAL HEMATOCRIT/OXYGEN SATURATIO
K931968
3M Health Care, Ltd.
Cardiovascular · 203d
Cleared Jan 15, 1992
CDI(TM) 300, 400 & 100, MODIFICATION
K915255
3M Company
Cardiovascular · 58d
Cleared Jan 15, 1992
CDI(TM) H/S CUVETTE, MODIFICATION
K915265
3M Company
Cardiovascular · 57d
Cleared Oct 15, 1991
SATURATION/HEMATOCRIT MONITOR SYSTEM
K910421
Medtronic Vascular
Cardiovascular · 258d
Cleared Jul 31, 1990
APPLICARD (EKG)
K900459
Medi-Globe Corp.
Cardiovascular · 182d

About Product Code DRY - Regulatory Context

510(k) Submission Activity

47 total 510(k) submissions under product code DRY since 1981, with 47 receiving FDA clearance (average review time: 97 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.