FDA Product Code DSK: Computer, Blood-pressure
Leading manufacturers include Hewlett-Packard Co., Endophys Technologies, LLC and Instrumentation Laboratory CO.
77
Total
77
Cleared
111d
Avg days
1977
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Computer, Blood-pressure Devices (Product Code DSK)
77 devices
Cleared
Nov 03, 2023
Endophys Blood Pressure Monitor model BPM-30
Endophys Technologies, LLC
Cardiovascular
156d
Cleared
Jan 14, 1987
SIRECUST 888/888R NON-INVASIVE BLOOD PRESS MONITOR
Siemens Medical Solutions USA, Inc.
Cardiovascular
155d
Cleared
Oct 18, 1982
MODEL 78553A PRESSURE PLUG-IN MODULE
Hewlett-Packard Co.
Cardiovascular
21d
Cleared
Jan 05, 1978
CARDIAC OUTPUT MODULE-78231C
Hewlett-Packard Co.
Cardiovascular
29d
Cleared
Jan 03, 1978
CARDIAC OUTPUT COMPUTER MODEL 701
Instrumentation Laboratory CO
Cardiovascular
78d
About Product Code DSK - Regulatory Context
510(k) Submission Activity
77 total 510(k) submissions under product code DSK since 1977, with 77 receiving FDA clearance (average review time: 111 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.