FDA Product Code DRY: Monitor, Blood-gas, On-line, Cardiopulmonary Bypass
Leading manufacturers include 3M Company, Spectrum Medical , Ltd. 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
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
Nov 06, 1997
3M CDI BLOOD PARAMETER MONITORING SYSTEM 500
3M Company
Cardiovascular
87d
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
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.