Product code DSK— Cardiovascular
6-415 FILTER, ELEMENT, 170-C
- Classification name
- Computer, Blood-Pressure
- Device class
- Class 2
- Regulation
- 21 CFR 870.1110
- Advisory panel
- Cardiovascular
- Total cleared
- 77
- First cleared
- Most recent
Market context for product code DSK
FDA has cleared devices under product code DSK between 1977 and 2023, filed by 54 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2023
- 2016
- 2015
- 2008
- 2007
- 2004
- 2002
- 2001
- 1999
- 1996
- 1994
- 1993
- 1992
- 1991
- 1990
Top applicants under product code DSK
Recent clearances under product code DSK
- K231586 — Endophys Blood Pressure Monitor model BPM-30
- K160945 — Endophys Blood Pressure Monitor
- K152582 — CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box
- K141615 — ENDOPHYS BLOOD PRESSURE MONITOR
- K080670 — MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM
- K070795 — SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM
- K033738 — MONITORING SYSTEM, MODEL ARGUS PB-2200
- K021517 — ABP FOR WINDOWS
- K013943 — RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720
- K011865 — ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION
- K003122 — SMARTFLOW, MODEL SFIP 2000
- K002742 — SPHYGMOCOR MX MODEL SCOR-MX
- K002067 — RADIANALYZER, MODEL 12710
- K983250 — INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONITOR
- K951226 — VITALMAX 4000/MINIPACK 3100/3000
- K943457 — AS/3 PRESSURE TEMPERATURE MODULE, M-PT
- K921388 — BIOCHEM 9100 MULTIGAS MONITOR IBP MODULE
- K925899 — AMBULATORY BLOOD PRESSURE MONITOR, MDL# 5100-01
- K914273 — A&D TM-2421/2021 AMBULATORY BLOOD PRESSURE MONITOR
- K912816 — PRESS 1 PRESS 2 9220 UPDATING OF THE MODULE
- K912833 — CAMINO MODEL M420: MONIT INTER W/MEAN PRES DISPLAY
- K903900 — SMU 611 VERS. 2.0 INCLUDING PRESSNI,DILU,SAT-MOD.
- K901514 — XR MODEL H PHYSIOLOGICAL MONITOR & RECORDING SYS.
- K896535 — MEDILOG OPTIMA
- K893232 — MODEL V420 DIRECT PRESSURE MONITOR & 427 WAVEFORM
- K884118 — TYPE 9220 PRESS 1 & 2 SYSTEM ATHENA
- K884938 — VITAL SIGNS MONITOR
- K885235 — SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS.
- K882085 — PROPAQ 104(TM)
- K882093 — CARDIOCAP(TM) CMO-104 MONITOR
- K880079 — TAKEDA MEDICAL AUTO. AMBU. BLOOD PRESS. METER/2420
- K874338 — TAKEDA MEDICAL BLOOD PRESSURE METER MODEL TM-2610
- K874339 — TAKEDA MEDICAL BLOOD PRESSURE METER MODEL TM-2620
- K873765 — FORTEC MI-100, MI-50 DIGITAL BLOOD PRESSURE METER
- K871720 — MODIFIED MODEL UA-731 DIGITAL SPHYGMOMANOMETER
- K871718 — MODIFIED MODEL UA-711 DIGITAL SPHYGMONOMETER
- K863042 — SIRECUST 888/888R NON-INVASIVE BLOOD PRESS MONITOR
- K862200 — FORTEC MI-100, BLOOD PRESSURE METER
- K862455 — MODIFIED CARDIOCAP MONITOR
- K862647 — PHYSIOLOGICAL MONITOR, MODELS 401,402 & 403
- K860689 — SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE
- K850879 — HORIZON 2000 PHYSIOLOGICAL PATIENT MONITOR
- K844396 — POLLENEX DIGITAL SPHYGMOMANOMETER BP-2000
- K844397 — POLLENEX DIGITAL SPHYGMOMANOMETER BP-4000
- K832017 — LME BLOOD PRESSURE MONITOR
- K831481 — DIXIE USA PTL, PHARYNGEAL TRACHEAL LUMEN
- K822843 — HTS *1
- K822878 — MODEL 78553A PRESSURE PLUG-IN MODULE
- K811146 — VITA-STAT MODEL 8000-C
- K811147 — VITA-STAT MODEL 9000-A
- K811148 — VITA-STAT MODEL 9000-S
- K811079 — SYPHGMOLOG
- K811208 — MODEL 1100 SPHYGMOMANOMETER
- K810635 — ELECTRODE BLOOD PRESSURE MONITOR
- K810171 — PERIPHERAL PULSE FUNCTION BLOCKS
- K810172 — PRESSURE FUNCTION BLOCKS
- K810178 — PATIENT MONITOR CM111, 112
- K810179 — DUAL TRACE PATIENT MONITOR 116,118,120
- K802925 — 6-415 FILTER, ELEMENT, 170-C
- K802600 — AMP PORTABLE PATIENT PRESSURE MONITOR
- K801110 — PRESSURE MONITOR, MODEL 1131B
- K800360 — OUTPUT DIGITAL DISPLAY MODULE, MOD. 611
- K792077 — MODEL 1981 PRESSUROMETER DATA ANALYSIS
- K791838 — HSH/H512 ADULT PHYSIOLOGICAL MONITORS
- K791839 — H59 CRITICAL CARE MONITOR
- K782073 — DINAMAP MODELS 1160 AND 1165
- K790135 — MONITOR, PRESSURVEIL
- K781701 — BLOOD PRESSURE, DIGITAL MODEL #2153
- K781053 — DINAMAP MODEL 846
- K781064 — DINAMAP MODEL 848
- K780798 — GOULD-STATHAM SP1405 PRESSURE MONITOR
- K780356 — OUTPUT DIGITAL DISPLAY MODULE, MODEL 401
- K772334 — MONITOR, CARDIAC, W/BLOOD PRESS.&TEMP
- K771981 — MINIMAP MODEL 810
- K772234 — CARDIAC OUTPUT MODULE-78231C
- K771977 — CARDIAC OUTPUT COMPUTER MODEL 701
- K771772 — DINAMAP MODEL 825A
Data sourced from openFDA. This site is unofficial and independent of the FDA.