DSK · Class II · 21 CFR 870.1110

FDA Product Code DSK: Computer, Blood-pressure

Leading manufacturers include A&D Engineering, Inc., Applied Medical Research and Honeywell, Inc..

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 Sep 26, 2016
Endophys Blood Pressure Monitor
K160945
Endophys Holdings, LLC
Cardiovascular · 174d
Cleared Dec 03, 2015
CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box
K152582
Volcano Corporation
Cardiovascular · 84d
Cleared Jan 07, 2015
ENDOPHYS BLOOD PRESSURE MONITOR
K141615
Endophys, Inc.
Cardiovascular · 205d
Cleared Aug 24, 2004
MONITORING SYSTEM, MODEL ARGUS PB-2200
K033738
Schiller AG
Cardiovascular · 270d
Cleared Dec 18, 2001
RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720
K013943
Radi Medical Systems AB
Cardiovascular · 19d
Cleared Jul 31, 2001
ZOLL M SERIES IBP OPERATION
K011865
Zoll Medical Corp
Cardiovascular · 47d
Cleared Jan 11, 2001
RADIANALYZER, MODEL 12710
K002067
Radi Medical Systems AB
Cardiovascular · 188d
Cleared Dec 12, 1999
INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONITOR
K983250
Magnetic Resonance Equipment Corp.
Cardiovascular · 452d
Cleared Nov 21, 1996
VITALMAX 4000/MINIPACK 3100/3000
K951226
Pace Tech, Inc.
Cardiovascular · 612d
Cleared Jul 27, 1994
AS/3 PRESSURE TEMPERATURE MODULE, M-PT
K943457
Datex Division Instrumentarium Corp.
Cardiovascular · 9d
Cleared May 26, 1993
BIOCHEM 9100 MULTIGAS MONITOR IBP MODULE
K921388
Biochem International, Inc.
Cardiovascular · 429d
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 Sep 23, 1991
CAMINO MODEL M420: MONIT INTER W/MEAN PRES DISPLAY
K912833
Camino Laboratories, Inc.
Cardiovascular · 89d
Cleared Nov 16, 1990
XR MODEL H PHYSIOLOGICAL MONITOR & RECORDING SYS.
K901514
Ppg Industries, Inc.
Cardiovascular · 231d
Cleared Jan 18, 1990
MEDILOG OPTIMA
K896535
Oxford Medilog, Inc.
Cardiovascular · 65d
Cleared Jul 14, 1989
MODEL V420 DIRECT PRESSURE MONITOR & 427 WAVEFORM
K893232
Camino Laboratories, Inc.
Cardiovascular · 77d
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

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.