Plethysmograph, Impedance
FDA product code DSB · Class II (moderate risk) · 21 CFR 870.2770 · Cardiovascular
115510(k) clearances
0PMA approvals
2recalls
Manufacturers
- Cardiodynamics International Corp. 11
- ImpediMed Limited 5
- Bomed Medical Mfr., Ltd. 4
- Noninvasive Medical Technologies, Inc. 4
- Vasocom, Inc. 3
- Electro-Diagnostic Instruments 3
- Life Sciences Manufacturing, Inc. 3
- Rjl Systems, Inc. 3
- Osypka Medical, Inc. 3
- Cardio Kinetics, Inc. 3
- Cheetah Medical, Inc. 3
- Seismed Instruments, Inc. 3
- Biodynamics Corp. 3
- Bomed Medical Mfg., Ltd. 2
- Body Composition Analog, Inc. 2
- E-Z-Em, Inc. 2
- Sorba Medical Systems, Inc. 2
- Sensible Medical Innovations , Ltd. 2
- Zynex Medical, Inc. 2
- Futrex, Inc. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260224 | MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)DSB · Traditional | ImpediMed Limited | 08/17/2026SE |
| K250634 | BCM2-Body Composition MonitorDSB · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 11/24/2025SE |
| K243727 | Re:BalansDSB · Traditional | Mode Sensors AS | 10/16/2025SE |
| K250922 | Edema Guard Monitor (EGM) CardioSet-001DSB · Traditional | Cardioset Medical , Ltd. | 09/09/2025SE |
| K232089 | SOZO ProDSB · Traditional | ImpediMed Limited | 10/17/2023SE |
| K223217 | Zynex Monitoring System, Model CM-1600DSB · Traditional | Zynex Medical, Inc. | 06/16/2023SE |
| K211585 | Bodyport Cardiac ScaleDSB · Traditional | Bodyport, Inc. | 07/29/2022SE |
| K203473 | SozoDSB · Traditional | ImpediMed Limited | 04/19/2021SE |
| K193410 | SOZO Body Fluid AnalyzerDSB · Traditional | ImpediMed Limited | 10/02/2020SE |
| K191697 | Cardiac Monitor 1500DSB · Traditional | Zynex Medical, Inc. | 02/21/2020SE |
| K180479 | ReDS SystemDSB · Traditional | Sensible Medical Innovations , Ltd. | 02/28/2019SE |
| K172431 | Cardiovascular AnalzyerDSB · Traditional | Physiowave, Inc. | 03/14/2018SE |
| K172507 | SozoDSB · Traditional | ImpediMed Limited | 12/22/2017SE |
| K172196 | ECOM Cardiac Output Monitoring SystemDSB · Traditional | Ecom Medical, Inc. | 09/19/2017SE |
| K150095 | ReDs Wearable SystemDSB · Traditional | Sensible Medical Innovations , Ltd. | 08/06/2015SE |
| K142503 | Imed-Z Fluid Status MonitorDSB · Traditional | Intersection Medical, Inc. | 06/05/2015SE |
| K140102 | Physioflow Q-LinkDSB · Special | Vasocom, Inc. | 02/12/2014SE |
| K133301 | Zoe Fluid Status MonitorDSB · Special | Noninvasive Medical Technologies, Inc. | 01/22/2014SE |
| K131765 | Ecom Endotracheal Cardiac Output Monitor SystemDSB · Traditional | Conmed Corporation | 12/20/2013SE |
| K131509 | Zoe Fluid Status MonitorDSB · Special | Noninvasive Medical Technologies, Inc. | 06/28/2013SE |
| K112830 | Zoefluid Status Monitor (Model Zoe 2B)DSB · Traditional | Noninvasive Medical Technologies, Inc. | 11/13/2012SE |
| K110645 | Bio Z Cardio Profile Hemodynamic MonitorDSB · Traditional | Sonosite,Inc. | 06/03/2011SE |
| K103166 | Cheetah ReliantDSB · Abbreviated | Cheetah Medical, Inc. | 01/25/2011SE |
| K103283 | Physioflow EnduroDSB · Special | Vasocom, Inc. | 12/03/2010SE |
| K080941 | Bioimpedance Cardiac Analyzing Measuring SystemDSB · Traditional | N.I. Medical, Ltd. | 06/18/2009SE |
| K090602 | Cardiodynamics Bioz RX, Model 7101-SYSDSB · Traditional | Cardiodynamics International Corp. | 05/28/2009SE |
| K083093 | Cheetah ReliantDSB · Abbreviated | Cheetah Medical, Inc. | 12/15/2008SE |
| K082242 | Icon, Model C3DSB · Special | Osypka Medical, Inc. | 10/08/2008SE |
| K081035 | Aesculon C2, Aesculon CHF Clinic C2, Aesculon Hypertension Clinic C2 and Aesculon…DSB · Special | Osypka Medical, Inc. | 05/30/2008SE |
| K060387 | Physioflow SystemDSB · Traditional | Vasocom, Inc. | 04/10/2008SE |
| K070985 | Aesculon CHF, Hypertension & Pacemaker ClinicDSB · Traditional | Osypka Medical, Inc. | 02/01/2008SE |
| K072662 | Cheetah Reliant, Cheetah ActiveDSB · Traditional | Cheetah Medical, Inc. | 01/16/2008SE |
| K070156 | Bioz DX Hemodynamic Monitor with Philips 12-LEAD ECG, Model 5100DSB · Traditional | Cardiodynamics International Corp. | 09/26/2007SE |
| K070500 | Bioimpedance Cardiac Analyzing Measuring System, Model Nicas 2004 SlimDSB · Traditional | Ni Medical | 07/16/2007SE |
| K051228 | Biozdx Hemodynamic Monitor and 12-LEAD ECGDSB · Traditional | Cardiodynamics International Corp. | 06/10/2005SE |
| K041294 | Biozdx Hemodynamic MonitorDSB · Traditional | Cardiodynamics International Corp. | 12/08/2004SE |
| K042113 | Zoe Fluid Status MonitorDSB · Special | Noninvasive Medical Technologies, LLC | 09/14/2004SE |
| K041434 | C3 and Lifegard Icg Impedance Cardiography MonitorsDSB · Traditional | Analogic Corp. | 08/06/2004SE |
| K032491 | Ecom CV4 Endotracheal Cardiac Output MonitorDSB · Special | Imagyn Medical Technologies, Inc. | 09/04/2003SESU |
| K021174 | Ecom Endotrachial Cardiac Output MonitorDSB · Traditional | Imagyn Surgical | 04/29/2003SESU |
| K014063 | Task Force Monitor 3040DSB · Traditional | Cnsystems Medizintechnik GmbH | 02/07/2002SE |
| K014299 | Sorba Steorra Non-Invasive Impedance CardiographDSB · Special | Sorba Medical Systems, Inc. | 01/30/2002SE |
| K011439 | Modification to Bioz.Com Hemodynamic MonitorDSB · Traditional | Cardiodynamics International Corp. | 11/02/2001SE |
| K011797 | Bioztect Sensor and Bioztect CableDSB · Special | Cardiodynamics International Corp. | 07/03/2001SE |
| K010164 | Icg ModuleDSB · Traditional | General Electric Medical Systems Information Techn | 04/09/2001SE |
| K001081 | Bioz.Pc Hemodynamic Monitor Model BZ-500/BZ-501; Bioz.Pc User Software Installation Kit…DSB · Traditional | Cardiodynamics International Corp. | 06/30/2000SE |
| K001100 | Bioz.Com Hemodynamic Monitor with Bioz Tect Sensor and Bioz Tect Cable Impedance…DSB · Special | Cardiodynamics International Corp. | 05/05/2000SE |
| K981720 | Iq SystemDSB · Traditional | Renaissance Technology, Inc. | 02/08/1999SE |
| K974725 | Bioz.Com SystemDSB · Traditional | Cardiodynamics International Corp. | 03/18/1998SE |
| K974621 | Percupump II with EdaDSB · Traditional | E-Z-Em, Inc. | 01/27/1998SE |
| K962783 | Edema SystemDSB · Traditional | Bioanalogics, Inc. | 10/23/1997SE |
| K972320 | Bioz System & Bioz PortableDSB · Traditional | Cardiodynamics International Corp. | 09/11/1997SE |
| K952172 | HotmanDSB · Traditional | Hemo Sapiens, Inc. | 06/10/1997SE |
| K970603 | D Series ElectrodeDSB · Traditional | Cmc Sense-It, Inc. | 04/01/1997SE |
| K961845 | Percupump II with EdaDSB · Traditional | E-Z-Em, Inc. | 01/23/1997SE |
| K963183 | Bioz SystemDSB · Traditional | Cardiodynamics International Corp. | 11/26/1996SE |
| K942227 | Nicas 2001 Noninvasive Cardio-Respiratory SystemDSB · Traditional | C.L. Mcintosh & Assoc., Inc. | 06/28/1996SE |
| K922601 | FUTREX-5000ADSB · Traditional | Futrex, Inc. | 12/28/1995SE |
| K922600 | FUTREX-5000DSB · Traditional | Futrex, Inc. | 12/28/1995SE |
| K951097 | BodystayDSB · Traditional | Bodystat , Ltd. | 11/22/1995SE |
| K950389 | Sorba Model CIC-1000 Non-Invasive Hemodynamic MonitorDSB · Traditional | Sorba Medical Systems, Inc. | 08/15/1995SE |
| K941162 | HypergraphDSB · Traditional | Dermed Diagnostics, Inc. | 12/15/1994SE |
| K930599 | Body Fat Analyzer Model TBF-105DSB · Traditional | Tanita Corp. of America | 11/01/1994SE |
| K932438 | Model IPM-1 Impedance Pulse MonitorDSB · Traditional | Electro-Diagnostic Instruments | 12/03/1993SE |
| K910994 | Modified SeismocardiographDSB · Traditional | Seismed Instruments, Inc. | 01/15/1992SE |
| K914200 | Vascumap Medical Air PlethysmographDSB · Traditional | Carolina Medical Electronics | 11/07/1991SE |
| K911194 | Impedance PHLEBOGRAPH/PHOTOPLETHYSMOGRAPH-DVT-2000DSB · Traditional | Rjl Systems, Inc. | 09/30/1991SE |
| K904970 | Body Composition AnalyzerDSB · Traditional | Body Composition Analog, Inc. | 03/07/1991SE |
| K903700 | Ipg-Ii ModuleDSB · Traditional | Life Sciences Manufacturing, Inc. | 01/16/1991SE |
| K904109 | Bio-Impedance AnalyzerDSB · Traditional | Xitron Technologies, Inc. | 01/08/1991SE |
| K902042 | Em-Scan HP-2 Pediatric Body Composition AnalyzerDSB · Traditional | Em-Scan, Inc. | 07/26/1990SE |
| K900213 | Pacemaker Patient Adaptor Module (Ppam)DSB · Traditional | Bomed Medical Mfg., Ltd. | 06/28/1990SE |
| K900321 | Dynatron 330 Body Composition AnalyzerDSB · Traditional | Dynatronics Laser Corp. | 06/11/1990SE |
| K900130 | Modified SeismocardiographDSB · Traditional | Seismed Instruments, Inc. | 03/28/1990SE |
| K895588 | Portable Air PlethysmographDSB · Traditional | Life Sciences Manufacturing, Inc. | 03/27/1990SE |
| K896034 | Procord MD3500 Vascular Diagnostic SystemDSB · Traditional | D. E. Hokanson, Inc. | 01/18/1990SE |
| K892323 | Seismocardiograph - Scg(Tm) 1000 SeriesDSB · Traditional | Seismed Instruments, Inc. | 10/30/1989SE |
| K894892 | HD-2200 Pneumo-Dop Vascular Testing SystemDSB · Traditional | Koven and Assoc., Inc. | 10/27/1989SE |
| K891928 | Holtain Body Composition AnalyserDSB · Traditional | Seritex, Inc. | 09/22/1989SE |
| K893963 | Veripoid 50 Bio-Electrical Impedance MeterDSB · Traditional | V.S.B.B. Technologies, Inc. | 09/05/1989SE |
| K890408 | Additional Software to Cardiodynamic MonitorDSB · Traditional | Bomed Medical Mfg., Ltd. | 06/01/1989SE |
| K883919 | Naparima Bioresistance Meter & Body Comp. AnalyzerDSB · Traditional | Naparima, Inc. | 12/16/1988SE |
| K881841 | Danninger Trimcheck(Tm) Portable & Desk Top ModelsDSB · Traditional | Buckman Co., Inc. | 12/13/1988SE |
| K884033 | Biodynamics Model 200 Body Composition AnalyzerDSB · Traditional | Biodynamics Corp. | 11/17/1988SE |
| K881291 | Air Plethysmograph Model APG-1000DSB · Traditional | Aci Medical, Inc. | 10/14/1988SE |
| K881851 | Veripoid 50 Bio-Electrical Impedance MeterDSB · Traditional | Micro Medical, Ltd. | 09/26/1988SE |
| K881968 | Biodynamics Model BI-400 Body Composition AnalyzerDSB · Traditional | Biodynamics Corp. | 07/28/1988SE |
| K874938 | Peripheral Vascular Laboratory Assistant Model 101DSB · Traditional | Sp Innovations, Inc. | 07/12/1988SE |
| K880926 | Biological Ohm Meter, Bes 200ZDSB · Traditional | Bioelectrical Sciences, Inc. | 06/15/1988SE |
| K874361 | Biodynamics Model BI-300 Body Composition AnalyzerDSB · Traditional | Biodynamics Corp. | 03/16/1988SE |
| K871040 | Consultant Body Composition AnalyzerDSB · Traditional | Body Composition Analog, Inc. | 06/05/1987SE |
| K863833 | Body Watch Body Composition Analyzer Model 2010DSB · Traditional | Body Watch, Inc. | 03/17/1987SE |
| K864889 | Omni-TrakDSB · Traditional | Invivo Research Labs, Inc. | 03/06/1987SE |
| K862383 | Modified Model BIA-103 Body Composition AnalyzerDSB · Traditional | Rjl Systems, Inc. | 02/03/1987SE |
| K861205 | 1990A Bio-Resistance Body Composition AnalyzerDSB · Traditional | Valhalla Scientific | 01/05/1987SE |
| K862714 | Bilateral Impedance Plethysmograph, Bip(Tm)DSB · Traditional | Electro-Diagnostic Instruments | 11/17/1986SE |
| K860749 | HA-2 Human Body Composition AnalyzerDSB · Traditional | Dj Medical Instrument Corp. C/O Keller & Heckman | 09/02/1986SE |
| K853706 | Bomed-CdmDSB · Traditional | Bomed Medical Mfr., Ltd. | 04/14/1986SE |
| K852238 | IPG-300DSB · Traditional | Thornton Associates, Inc. | 10/11/1985SE |
| K851415 | Body Analysis System (Deemed Se 87/09/18)DSB · Traditional | Medi-Sport Testing, Inc. | 07/08/1985SE |
| K852378 | Light Reflection RheographyDSB · Traditional | Hemodynamics, Inc. | 06/20/1985SE |
| K833728 | Cardiac Wall Motion DeviceDSB · Traditional | Intl. Medical, Inc. | 02/10/1984SE |
| K833155 | Rayden Medical Mini Pulse Volume RecordDSB · Traditional | Burditt & Calkins-Siemens-Elema | 01/26/1984SE |
| K831422 | BioflowDSB · Traditional | Bomed Medical Mfr., Ltd. | 09/12/1983SE |
| K831421 | Bomed BioconDSB · Traditional | Bomed Medical Mfr., Ltd. | 09/12/1983SE |
| K830292 | Bioelectrical Impedance Analyzer #101DSB · Traditional | Rjl Systems, Inc. | 08/12/1983SE |
| K823215 | CKG 8800DSB · Traditional | Cardio Kinetics, Inc. | 11/24/1982SE |
| K822522 | Cutaneous Pressure PlethysmographDSB · Traditional | Life Sciences Manufacturing, Inc. | 09/28/1982SE |
| K822455 | Vasograph, Model MV-2DSB · Traditional | Electro-Diagnostic Instruments | 09/24/1982SE |
| K822020 | CKG 8000DSB · Traditional | Cardio Kinetics, Inc. | 08/06/1982SE |
| K820959 | Blood Flow AnalyzerDSB · Traditional | Biofax Medical Instrumentation Co. | 05/25/1982SE |
| K811999 | Bo Med BiaDSB · Traditional | Bomed Medical Mfr., Ltd. | 08/31/1981SE |
| K792051 | CKG CardiokymographDSB · Traditional | Cardio Kinetics, Inc. | 11/13/1979SE |
| K781352 | Strain Gauge PlethysmographDSB · Traditional | Medimatic | 10/27/1978SE |
| K772092 | Chest Fluid MonitorDSB · Traditional | Dynatech Research & Development Co. | 11/18/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1817-2022 Class III | Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5…Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are… | Baxter Healthcare Corporation | 09/02/2022Open, Classified |
| Z-0572-2016 Class II | CNSystems TASK FORCE MONITOR 3040i, plethysmograph, impedance. Noninvasively measure and…Device non-conformity which may lead to an incorrect oscillometric measurement of upper arm blood pressure… | Partners In Medicine Llc | 12/01/2015Terminated |