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DSB

114 FDA 510(k) clearances · Product code

132 daysmedian time to decision
371 days90th percentile
114clearances measured

FDA profile

Official device name
Plethysmograph, Impedance
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2770
Medical specialty
Cardiovascular
Flags
Third-party review eligible
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RecordFirmDate
BCM2-Body Composition Monitor (K250634)Fresenius Medical Care Renal Therapies Group, LLC2025-11-24
Re:Balans (K243727)Mode Sensors AS2025-10-16
Edema Guard Monitor (EGM) CardioSet-001 (K250922)Cardioset Medical , Ltd.2025-09-09
SOZO Pro (K232089)ImpediMed Limited2023-10-17
Zynex Monitoring System, Model CM-1600 (K223217)Zynex Medical, Inc.2023-06-16
Bodyport Cardiac Scale (K211585)Bodyport, Inc.2022-07-29
SOZO (K203473)ImpediMed Limited2021-04-19
SOZO Body Fluid Analyzer (K193410)ImpediMed Limited2020-10-02
Cardiac Monitor 1500 (K191697)Zynex Medical, Inc.2020-02-21
ReDS System (K180479)Sensible Medical Innovations , Ltd.2019-02-28
Cardiovascular Analzyer (K172431)Physiowave, Inc.2018-03-14
SOZO (K172507)ImpediMed Limited2017-12-22
ECOM™ Cardiac Output Monitoring System (K172196)Ecom Medical, Inc.2017-09-19
ReDs Wearable System (K150095)Sensible Medical Innovations , Ltd.2015-08-06
IMED-Z FLUID STATUS MONITOR (K142503)Intersection Medical, Inc.2015-06-05
PHYSIOFLOW Q-LINK (K140102)Vasocom, Inc.2014-02-12
ZOE FLUID STATUS MONITOR (K133301)Noninvasive Medical Technologies, Inc.2014-01-22
ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM (K131765)Conmed Corporation2013-12-20
ZOE FLUID STATUS MONITOR (K131509)Noninvasive Medical Technologies, Inc.2013-06-28
ZOEFLUID STATUS MONITOR (MODEL ZOE 2B) (K112830)Noninvasive Medical Technologies, Inc.2012-11-13
BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR (K110645)Sonosite,Inc.2011-06-03
CHEETAH RELIANT (K103166)Cheetah Medical, Inc.2011-01-25
PHYSIOFLOW ENDURO (K103283)Vasocom, Inc.2010-12-03
BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM (K080941)N.I. Medical, Ltd.2009-06-18
CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS (K090602)Cardiodynamics International Corp.2009-05-28
CHEETAH RELIANT (K083093)Cheetah Medical, Inc.2008-12-15
ICON, MODEL C3 (K082242)Osypka Medical, Inc.2008-10-08
AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2 (K081035)Osypka Medical, Inc.2008-05-30
PHYSIOFLOW SYSTEM (K060387)Vasocom, Inc.2008-04-10
AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC (K070985)Osypka Medical, Inc.2008-02-01
CHEETAH RELIANT, CHEETAH ACTIVE (K072662)Cheetah Medical, Inc.2008-01-16
BIOZ DX HEMODYNAMIC MONITOR WITH PHILIPS 12-LEAD ECG, MODEL 5100 (K070156)Cardiodynamics International Corp.2007-09-26
BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM, MODEL NICAS 2004 SLIM (K070500)Ni Medical2007-07-16
BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG (K051228)Cardiodynamics International Corp.2005-06-10
BIOZDX HEMODYNAMIC MONITOR (K041294)Cardiodynamics International Corp.2004-12-08
ZOE FLUID STATUS MONITOR (K042113)Noninvasive Medical Technologies, LLC2004-09-14
C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS (K041434)Analogic Corp.2004-08-06
ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR (K032491)Imagyn Medical Technologies, Inc.2003-09-04
ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR (K021174)Imagyn Surgical2003-04-29
TASK FORCE MONITOR 3040 (K014063)Cnsystems Medizintechnik GmbH2002-02-07
SORBA STEORRA NON-INVASIVE IMPEDANCE CARDIOGRAPH (K014299)Sorba Medical Systems, Inc.2002-01-30
MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR (K011439)Cardiodynamics International Corp.2001-11-02
BIOZTECT SENSOR AND BIOZTECT CABLE (K011797)Cardiodynamics International Corp.2001-07-03
ICG MODULE (K010164)General Electric Medical Systems Information Techn2001-04-09
BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810 (K001081)Cardiodynamics International Corp.2000-06-30
BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE IMPEDANCE PLETHYSMOGRAPH (K001100)Cardiodynamics International Corp.2000-05-05
IQ SYSTEM (K981720)Renaissance Technology, Inc.1999-02-08
BIOZ.COM SYSTEM (K974725)Cardiodynamics International Corp.1998-03-18
PERCUPUMP II WITH EDA (K974621)E-Z-Em, Inc.1998-01-27
EDEMA SYSTEM (K962783)Bioanalogics, Inc.1997-10-23
BIOZ SYSTEM & BIOZ PORTABLE (K972320)Cardiodynamics International Corp.1997-09-11
HOTMAN (K952172)Hemo Sapiens, Inc.1997-06-10
D SERIES ELECTRODE (K970603)Cmc Sense-It, Inc.1997-04-01
PERCUPUMP II WITH EDA (K961845)E-Z-Em, Inc.1997-01-23
BIOZ SYSTEM (K963183)Cardiodynamics International Corp.1996-11-26
NICAS 2001 NONINVASIVE CARDIO-RESPIRATORY SYSTEM (K942227)C.L. Mcintosh & Assoc., Inc.1996-06-28
FUTREX-5000 (K922600)Futrex, Inc.1995-12-28
FUTREX-5000A (K922601)Futrex, Inc.1995-12-28
BODYSTAY (K951097)Bodystat , Ltd.1995-11-22
SORBA MODEL CIC-1000 NON-INVASIVE HEMODYNAMIC MONITOR (K950389)Sorba Medical Systems, Inc.1995-08-15
HYPERGRAPH (K941162)Dermed Diagnostics, Inc.1994-12-15
BODY FAT ANALYZER MODEL TBF-105 (K930599)Tanita Corp. of America1994-11-01
MODEL IPM-1 IMPEDANCE PULSE MONITOR (K932438)Electro-Diagnostic Instruments1993-12-03
MODIFIED SEISMOCARDIOGRAPH (K910994)Seismed Instruments, Inc.1992-01-15
VASCUMAP MEDICAL AIR PLETHYSMOGRAPH (K914200)Carolina Medical Electronics1991-11-07
IMPEDANCE PHLEBOGRAPH/PHOTOPLETHYSMOGRAPH-DVT-2000 (K911194)Rjl Systems, Inc.1991-09-30
BODY COMPOSITION ANALYZER (K904970)Body Composition Analog, Inc.1991-03-07
IPG-II MODULE (K903700)Life Sciences Manufacturing, Inc.1991-01-16
BIO-IMPEDANCE ANALYZER (K904109)Xitron Technologies, Inc.1991-01-08
EM-SCAN HP-2 PEDIATRIC BODY COMPOSITION ANALYZER (K902042)Em-Scan, Inc.1990-07-26
PACEMAKER PATIENT ADAPTOR MODULE (PPAM) (K900213)Bomed Medical Mfg., Ltd.1990-06-28
DYNATRON 330 BODY COMPOSITION ANALYZER (K900321)Dynatronics Laser Corp.1990-06-11
MODIFIED SEISMOCARDIOGRAPH (K900130)Seismed Instruments, Inc.1990-03-28
PORTABLE AIR PLETHYSMOGRAPH (K895588)Life Sciences Manufacturing, Inc.1990-03-27
PROCORD MD3500 VASCULAR DIAGNOSTIC SYSTEM (K896034)D. E. Hokanson, Inc.1990-01-18
SEISMOCARDIOGRAPH - SCG(TM) 1000 SERIES (K892323)Seismed Instruments, Inc.1989-10-30
HD-2200 PNEUMO-DOP VASCULAR TESTING SYSTEM (K894892)Koven and Assoc., Inc.1989-10-27
HOLTAIN BODY COMPOSITION ANALYSER (K891928)Seritex, Inc.1989-09-22
VERIPOID 50 BIO-ELECTRICAL IMPEDANCE METER (K893963)V.S.B.B. Technologies, Inc.1989-09-05
ADDITIONAL SOFTWARE TO CARDIODYNAMIC MONITOR (K890408)Bomed Medical Mfg., Ltd.1989-06-01
NAPARIMA BIORESISTANCE METER & BODY COMP. ANALYZER (K883919)Naparima, Inc.1988-12-16
DANNINGER TRIMCHECK(TM) PORTABLE & DESK TOP MODELS (K881841)Buckman Co., Inc.1988-12-13
BIODYNAMICS MODEL 200 BODY COMPOSITION ANALYZER (K884033)Biodynamics Corp.1988-11-17
AIR PLETHYSMOGRAPH MODEL APG-1000 (K881291)Aci Medical, Inc.1988-10-14
VERIPOID 50 BIO-ELECTRICAL IMPEDANCE METER (K881851)Micro Medical, Ltd.1988-09-26
BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER (K881968)Biodynamics Corp.1988-07-28
PERIPHERAL VASCULAR LABORATORY ASSISTANT MODEL 101 (K874938)Sp Innovations, Inc.1988-07-12
BIOLOGICAL OHM METER, BES 200Z (K880926)Bioelectrical Sciences, Inc.1988-06-15
BIODYNAMICS MODEL BI-300 BODY COMPOSITION ANALYZER (K874361)Biodynamics Corp.1988-03-16
CONSULTANT BODY COMPOSITION ANALYZER (K871040)Body Composition Analog, Inc.1987-06-05
BODY WATCH BODY COMPOSITION ANALYZER MODEL 2010 (K863833)Body Watch, Inc.1987-03-17
OMNI-TRAK (K864889)Invivo Research Labs, Inc.1987-03-06
MODIFIED MODEL BIA-103 BODY COMPOSITION ANALYZER (K862383)Rjl Systems, Inc.1987-02-03
1990A BIO-RESISTANCE BODY COMPOSITION ANALYZER (K861205)Valhalla Scientific1987-01-05
BILATERAL IMPEDANCE PLETHYSMOGRAPH, BIP(TM) (K862714)Electro-Diagnostic Instruments1986-11-17
HA-2 HUMAN BODY COMPOSITION ANALYZER (K860749)Dj Medical Instrument Corp. C/O Keller & Heckman1986-09-02
BOMED-CDM (K853706)Bomed Medical Mfr., Ltd.1986-04-14
IPG-300 (K852238)Thornton Associates, Inc.1985-10-11
BODY ANALYSIS SYSTEM (DEEMED SE 87/09/18) (K851415)Medi-Sport Testing, Inc.1985-07-08
LIGHT REFLECTION RHEOGRAPHY (K852378)Hemodynamics, Inc.1985-06-20
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