DSK · Class II · 21 CFR 870.1110

FDA Product Code DSK: Computer, Blood-pressure

Leading manufacturers include A&D Engineering, Inc., Honeywell, Inc. and Datex Division Instrumentarium Corp..

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
1–24 of 77
Cleared Nov 03, 2023
Endophys Blood Pressure Monitor model BPM-30
K231586
Endophys Technologies, LLC
Cardiovascular · 156d
Cleared Dec 03, 2015
CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box
K152582
Volcano Corporation
Cardiovascular · 84d
Cleared Jul 27, 1994
AS/3 PRESSURE TEMPERATURE MODULE, M-PT
K943457
Datex Division Instrumentarium Corp.
Cardiovascular · 9d
Cleared May 21, 1993
AMBULATORY BLOOD PRESSURE MONITOR, MDL# 5100-01
K925899
Welch Allyn, Inc.
Cardiovascular · 182d
Cleared Feb 09, 1993
A&D TM-2421/2021 AMBULATORY BLOOD PRESSURE MONITOR
K914273
A&D Engineering, Inc.
Cardiovascular · 504d
Cleared Apr 10, 1992
PRESS 1 PRESS 2 9220 UPDATING OF THE MODULE
K912816
S & W Medico Teknik
Cardiovascular · 297d
Cleared Jan 18, 1990
MEDILOG OPTIMA
K896535
Oxford Medilog, Inc.
Cardiovascular · 65d
Cleared Apr 25, 1989
TYPE 9220 PRESS 1 & 2 SYSTEM ATHENA
K884118
S & W Medico Teknik
Cardiovascular · 207d
Cleared Jul 28, 1988
CARDIOCAP(TM) CMO-104 MONITOR
K882093
Datex Division Instrumentarium Corp.
Cardiovascular · 70d
Cleared Mar 31, 1988
TAKEDA MEDICAL AUTO. AMBU. BLOOD PRESS. METER/2420
K880079
A&D Engineering, Inc.
Cardiovascular · 80d
Cleared Feb 05, 1988
TAKEDA MEDICAL BLOOD PRESSURE METER MODEL TM-2610
K874338
A&D Engineering, Inc.
Cardiovascular · 107d
Cleared Dec 18, 1987
TAKEDA MEDICAL BLOOD PRESSURE METER MODEL TM-2620
K874339
A&D Engineering, Inc.
Cardiovascular · 58d
Cleared Jul 29, 1987
MODIFIED MODEL UA-731 DIGITAL SPHYGMOMANOMETER
K871720
A&D Engineering, Inc.
Cardiovascular · 86d
Cleared Jun 24, 1987
MODIFIED MODEL UA-711 DIGITAL SPHYGMONOMETER
K871718
A&D Engineering, Inc.
Cardiovascular · 51d
Cleared Jan 14, 1987
SIRECUST 888/888R NON-INVASIVE BLOOD PRESS MONITOR
K863042
Siemens Medical Solutions USA, Inc.
Cardiovascular · 155d
Cleared Sep 24, 1986
MODIFIED CARDIOCAP MONITOR
K862455
Datex Division Instrumentarium Corp.
Cardiovascular · 89d
Cleared Jul 30, 1986
SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE
K860689
Spacelabs, Inc.
Cardiovascular · 155d
Cleared Apr 25, 1985
HORIZON 2000 PHYSIOLOGICAL PATIENT MONITOR
K850879
Mennen Medical, Inc.
Cardiovascular · 52d
Cleared Oct 31, 1983
LME BLOOD PRESSURE MONITOR
K832017
Litton Medical Electronics
Cardiovascular · 130d
Cleared Oct 18, 1982
MODEL 78553A PRESSURE PLUG-IN MODULE
K822878
Hewlett-Packard Co.
Cardiovascular · 21d
Cleared May 21, 1981
MODEL 1100 SPHYGMOMANOMETER
K811208
Y
Cardiovascular · 20d
Cleared Feb 25, 1981
PERIPHERAL PULSE FUNCTION BLOCKS
K810171
Honeywell, Inc.
Cardiovascular · 34d
Cleared Feb 25, 1981
PRESSURE FUNCTION BLOCKS
K810172
Honeywell, Inc.
Cardiovascular · 34d
Cleared Feb 25, 1981
PATIENT MONITOR CM111, 112
K810178
Honeywell, Inc.
Cardiovascular · 34d

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.