FDA Product Code DRY: Monitor, Blood-gas, On-line, Cardiopulmonary Bypass
Leading manufacturers include 3M Company, Spectrum Medical , Ltd. and Terumo Cardiovascular Systems Corp..
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
Cleared
Apr 25, 2024
CDI OneView Monitoring System
Terumo Cardiovascular Systems Corporation
Cardiovascular
125d
Cleared
Apr 01, 2021
B-Capta
Livanova Deutschland, GmbH
Cardiovascular
241d
Cleared
Oct 02, 2020
Quantum Workstation 12 Elite
Spectrum Medical , Ltd.
Cardiovascular
29d
Cleared
Nov 02, 2018
CDI Blood Parameter Monitoring System 550
Terumo Cardiovascular Systems Corporation
Cardiovascular
88d
Cleared
Aug 17, 2018
Quantum Workstation 12.1
Spectrum Medical , Ltd.
Cardiovascular
30d
Cleared
Mar 28, 2018
Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas
Spectrum Medical , Ltd.
Cardiovascular
127d
Cleared
Oct 23, 2014
TRI-OPTIC MEASUREMENT CELL
Medtronic, Inc.
Cardiovascular
371d
Cleared
Jul 25, 2014
CDI BLOOD PARAMETER MONITORING SYSTEM 500
Terumo Cardiovascular Systems Corp.
Cardiovascular
240d
Cleared
Nov 20, 2012
CDI BLOOD PARAMETER MONITORING SYSTEM 500
Terumo Cardiovascular Systems Corp.
Cardiovascular
53d
Cleared
Apr 22, 2009
BLOOD MONITORING UNIT, MODEL BMU 40
Maquet Cardiopulmonary, AG
Cardiovascular
91d
Cleared
Nov 06, 1997
3M CDI BLOOD PARAMETER MONITORING SYSTEM 500
3M Company
Cardiovascular
87d
Cleared
Nov 10, 1993
CDI 100 EXTRACORPOREAL HEMATOCRIT/OXYGEN SATURATIO
3M Health Care, Ltd.
Cardiovascular
203d
Cleared
Jan 15, 1992
CDI(TM) 300, 400 & 100, MODIFICATION
3M Company
Cardiovascular
58d
Cleared
Jan 15, 1992
CDI(TM) H/S CUVETTE, MODIFICATION
3M Company
Cardiovascular
57d
Cleared
Oct 15, 1991
SATURATION/HEMATOCRIT MONITOR SYSTEM
Medtronic Vascular
Cardiovascular
258d
Cleared
May 24, 1988
STOCKERT-SHILEY BUBBLE MONITOR 23-23-01
Shiley, Inc.
Cardiovascular
76d
Cleared
May 13, 1988
STAT-SAT
Gish Biomedical, Inc.
Cardiovascular
171d
Cleared
Sep 16, 1985
HEMATOCRIT-SATURATION MONITOR HSM-100
American Bentley
Cardiovascular
124d
Cleared
Oct 24, 1984
COBE SATURATION CELL
Cobe Laboratories, Inc.
Cardiovascular
33d
Cleared
Jan 05, 1983
OXYGEN CONSUMPTION MONITOR #OCM-0100
Bentley Laboratories, Inc.
Cardiovascular
61d
Cleared
May 25, 1982
IN-LINE OXYGEN MONITORING SYSTEM
G.D. Searle and Co.
Cardiovascular
33d
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.