Atlas FDA

DSK

77 FDA 510(k) clearances · Product code

73 daysmedian time to decision
231 days90th percentile
77clearances measured

FDA profile

Official device name
Computer, Blood-Pressure
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1110
Medical specialty
Cardiovascular
Flags
Third-party review eligible
Adverse events (MAUDE)
2019: 148 · 2020: 29 · 2021: 31 · 2022: 29 · 2025: 26 · 2026: 34
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Endophys Blood Pressure Monitor model BPM-30 (K231586)Endophys Technologies, LLC2023-11-03
Endophys Blood Pressure Monitor (K160945)Endophys Holdings, LLC2016-09-26
CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box (K152582)Volcano Corporation2015-12-03
ENDOPHYS BLOOD PRESSURE MONITOR (K141615)Endophys, Inc.2015-01-07
MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM (K080670)Atcor Medical2008-04-23
SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM (K070795)Atcor Medical Pty, Ltd.2007-08-31
MONITORING SYSTEM, MODEL ARGUS PB-2200 (K033738)Schiller AG2004-08-24
ABP FOR WINDOWS (K021517)Rozinn Electronics, Inc.2002-07-24
RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720 (K013943)Radi Medical Systems AB2001-12-18
ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION (K011865)Zoll Medical Corp2001-07-31
SMARTFLOW, MODEL SFIP 2000 (K003122)Florence Medical , Ltd.2001-05-14
SPHYGMOCOR MX MODEL SCOR-MX (K002742)Pwv Medical Pty, Lt.2001-05-01
RADIANALYZER, MODEL 12710 (K002067)Radi Medical Systems AB2001-01-11
INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONITOR (K983250)Magnetic Resonance Equipment Corp.1999-12-12
VITALMAX 4000/MINIPACK 3100/3000 (K951226)Pace Tech, Inc.1996-11-21
AS/3 PRESSURE TEMPERATURE MODULE, M-PT (K943457)Datex Division Instrumentarium Corp.1994-07-27
BIOCHEM 9100 MULTIGAS MONITOR IBP MODULE (K921388)Biochem International, Inc.1993-05-26
AMBULATORY BLOOD PRESSURE MONITOR, MDL# 5100-01 (K925899)Welch Allyn, Inc.1993-05-21
A&D TM-2421/2021 AMBULATORY BLOOD PRESSURE MONITOR (K914273)A&D Engineering, Inc.1993-02-09
PRESS 1 PRESS 2 9220 UPDATING OF THE MODULE (K912816)S & W Medico Teknik1992-04-10
CAMINO MODEL M420: MONIT INTER W/MEAN PRES DISPLAY (K912833)Camino Laboratories, Inc.1991-09-23
SMU 611 VERS. 2.0 INCLUDING PRESSNI,DILU,SAT-MOD. (K903900)Ppg Hellige B.V.1991-01-08
XR MODEL H PHYSIOLOGICAL MONITOR & RECORDING SYS. (K901514)Ppg Industries, Inc.1990-11-16
MEDILOG OPTIMA (K896535)Oxford Medilog, Inc.1990-01-18
MODEL V420 DIRECT PRESSURE MONITOR & 427 WAVEFORM (K893232)Camino Laboratories, Inc.1989-07-14
TYPE 9220 PRESS 1 & 2 SYSTEM ATHENA (K884118)S & W Medico Teknik1989-04-25
VITAL SIGNS MONITOR (K884938)Tico Medical Instruments, Inc.1989-04-19
SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS. (K885235)Spectramed, Inc.1989-01-25
CARDIOCAP(TM) CMO-104 MONITOR (K882093)Datex Division Instrumentarium Corp.1988-07-28
PROPAQ 104(TM) (K882085)Protocol Systems, Inc.1988-07-28
TAKEDA MEDICAL AUTO. AMBU. BLOOD PRESS. METER/2420 (K880079)A&D Engineering, Inc.1988-03-31
TAKEDA MEDICAL BLOOD PRESSURE METER MODEL TM-2610 (K874338)A&D Engineering, Inc.1988-02-05
TAKEDA MEDICAL BLOOD PRESSURE METER MODEL TM-2620 (K874339)A&D Engineering, Inc.1987-12-18
FORTEC MI-100, MI-50 DIGITAL BLOOD PRESSURE METER (K873765)Nam Tai , Ltd.1987-10-09
MODIFIED MODEL UA-731 DIGITAL SPHYGMOMANOMETER (K871720)A&D Engineering, Inc.1987-07-29
MODIFIED MODEL UA-711 DIGITAL SPHYGMONOMETER (K871718)A&D Engineering, Inc.1987-06-24
SIRECUST 888/888R NON-INVASIVE BLOOD PRESS MONITOR (K863042)Siemens Medical Solutions USA, Inc.1987-01-14
FORTEC MI-100, BLOOD PRESSURE METER (K862200)Fortec Electronic Corp./Nam Tai1986-11-18
MODIFIED CARDIOCAP MONITOR (K862455)Datex Division Instrumentarium Corp.1986-09-24
PHYSIOLOGICAL MONITOR, MODELS 401,402 & 403 (K862647)Ivy Biomedical Systems, Inc.1986-08-18
SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE (K860689)Spacelabs, Inc.1986-07-30
HORIZON 2000 PHYSIOLOGICAL PATIENT MONITOR (K850879)Mennen Medical, Inc.1985-04-25
POLLENEX DIGITAL SPHYGMOMANOMETER BP-4000 (K844397)Associated Mills, Inc.1985-04-18
POLLENEX DIGITAL SPHYGMOMANOMETER BP-2000 (K844396)Associated Mills, Inc.1985-04-18
LME BLOOD PRESSURE MONITOR (K832017)Litton Medical Electronics1983-10-31
DIXIE USA PTL, PHARYNGEAL TRACHEAL LUMEN (K831481)Eugene Scarberry1983-10-04
HTS *1 (K822843)Global Office Automation System, Inc.1982-12-15
MODEL 78553A PRESSURE PLUG-IN MODULE (K822878)Hewlett-Packard Co.1982-10-18
VITA-STAT MODEL 9000-A (K811147)Vita-Stat1981-06-30
VITA-STAT MODEL 9000-S (K811148)Viat-Stat1981-06-30
VITA-STAT MODEL 8000-C (K811146)Vita-Stat1981-06-30
SYPHGMOLOG (K811079)Cardiodyne General, Inc.1981-06-12
MODEL 1100 SPHYGMOMANOMETER (K811208)Y1981-05-21
ELECTRODE BLOOD PRESSURE MONITOR (K810635)Sears, Roebuck & Co.1981-05-08
PERIPHERAL PULSE FUNCTION BLOCKS (K810171)Honeywell, Inc.1981-02-25
PRESSURE FUNCTION BLOCKS (K810172)Honeywell, Inc.1981-02-25
DUAL TRACE PATIENT MONITOR 116,118,120 (K810179)Honeywell, Inc.1981-02-25
PATIENT MONITOR CM111, 112 (K810178)Honeywell, Inc.1981-02-25
6-415 FILTER, ELEMENT, 170-C (K802925)Lifecare Services, Inc.1980-12-19
AMP PORTABLE PATIENT PRESSURE MONITOR (K802600)American Medical Products, Inc.1980-11-12
PRESSURE MONITOR, MODEL 1131B (K801110)American Optical Corp.1980-05-20
OUTPUT DIGITAL DISPLAY MODULE, MOD. 611 (K800360)Output, Inc.1980-02-29
MODEL 1981 PRESSUROMETER DATA ANALYSIS (K792077)Del Mar Avionics1979-12-04
HSH/H512 ADULT PHYSIOLOGICAL MONITORS (K791838)Medtel Pty. , Ltd.1979-10-01
H59 CRITICAL CARE MONITOR (K791839)Medtel Pty. , Ltd.1979-10-01
DINAMAP MODELS 1160 AND 1165 (K782073)Applied Medical Research1979-02-23
MONITOR, PRESSURVEIL (K790135)Concept, Inc.1979-02-13
BLOOD PRESSURE, DIGITAL MODEL #2153 (K781701)Sears, Roebuck & Co.1978-12-04
DINAMAP MODEL 848 (K781064)Applied Medical Research1978-09-07
DINAMAP MODEL 846 (K781053)Applied Medical Research1978-09-07
GOULD-STATHAM SP1405 PRESSURE MONITOR (K780798)Gould, Inc.1978-06-13
OUTPUT DIGITAL DISPLAY MODULE, MODEL 401 (K780356)Output, Inc.1978-05-31
MONITOR, CARDIAC, W/BLOOD PRESS.&TEMP (K772334)Telectronics, Inc.1978-02-21
MINIMAP MODEL 810 (K771981)Applied Medical Research1978-01-24
CARDIAC OUTPUT MODULE-78231C (K772234)Hewlett-Packard Co.1978-01-05
CARDIAC OUTPUT COMPUTER MODEL 701 (K771977)Instrumentation Laboratory CO1978-01-03
DINAMAP MODEL 825A (K771772)Applied Medical Research1977-10-04

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Every clearance here is in the API, with alerts when new ones post.