Product Code: DSB FDA class 2 21 CFR 870.2770

Plethysmograph, Impedance

Cardiovascular

The Impedance Plethysmograph is a cardiovascular diagnostic device used to measure changes in blood volume within a body segment by detecting variations in electrical impedance, helping assess venous thrombosis, arterial occlusion, or cardiac output. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DSB and it is regulated under 21 CFR 870.2770 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

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510(k)s

114

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: DSB
Device Class: FDA class 2
Regulation Number: 870.2770
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 114 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K250634	BCM2-Body Composition Monitor	Nov 24, 2025	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC
K243727	Re:Balans	Oct 16, 2025	Substantially Equivalent	Mode Sensors AS
K250922	Edema Guard Monitor (EGM) CardioSet-001	Sep 09, 2025	Substantially Equivalent	Cardioset Medical , Ltd.
K232089	SOZO Pro	Oct 17, 2023	Substantially Equivalent	ImpediMed Limited
K223217	Zynex Monitoring System, Model CM-1600	Jun 16, 2023	Substantially Equivalent	Zynex Medical, Inc.
K211585	Bodyport Cardiac Scale	Jul 29, 2022	Substantially Equivalent	Bodyport, Inc.
K203473	SOZO	Apr 19, 2021	Substantially Equivalent	ImpediMed Limited
K193410	SOZO Body Fluid Analyzer	Oct 02, 2020	Substantially Equivalent	ImpediMed Limited
K191697	Cardiac Monitor 1500	Feb 21, 2020	Substantially Equivalent	Zynex Medical, Inc.
K180479	ReDS System	Feb 28, 2019	Substantially Equivalent	Sensible Medical Innovations , Ltd.
K172431	Cardiovascular Analzyer	Mar 14, 2018	Substantially Equivalent	Physiowave, Inc.
K172507	SOZO	Dec 22, 2017	Substantially Equivalent	ImpediMed Limited
K172196	ECOM Cardiac Output Monitoring System	Sep 19, 2017	Substantially Equivalent	Ecom Medical, Inc.
K150095	ReDs Wearable System	Aug 06, 2015	Substantially Equivalent	Sensible Medical Innovations , Ltd.
K142503	IMED-Z FLUID STATUS MONITOR	Jun 05, 2015	Substantially Equivalent	Intersection Medical, Inc.
K140102	PHYSIOFLOW Q-LINK	Feb 12, 2014	Substantially Equivalent	Vasocom, Inc.
K133301	ZOE FLUID STATUS MONITOR	Jan 22, 2014	Substantially Equivalent	Noninvasive Medical Technologies, Inc.
K131765	ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM	Dec 20, 2013	Substantially Equivalent	Conmed Corporation
K131509	ZOE FLUID STATUS MONITOR	Jun 28, 2013	Substantially Equivalent	Noninvasive Medical Technologies, Inc.
K112830	ZOEFLUID STATUS MONITOR (MODEL ZOE 2B)	Nov 13, 2012	Substantially Equivalent	Noninvasive Medical Technologies, Inc.
K110645	BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR	Jun 03, 2011	Substantially Equivalent	Sonosite,Inc.
K103166	CHEETAH RELIANT	Jan 25, 2011	Substantially Equivalent	Cheetah Medical, Inc.
K103283	PHYSIOFLOW ENDURO	Dec 03, 2010	Substantially Equivalent	Vasocom, Inc.
K080941	BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM	Jun 18, 2009	Substantially Equivalent	N.I. Medical, Ltd.
K090602	CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS	May 28, 2009	Substantially Equivalent	Cardiodynamics International Corp.
K083093	CHEETAH RELIANT	Dec 15, 2008	Substantially Equivalent	Cheetah Medical, Inc.
K082242	ICON, MODEL C3	Oct 08, 2008	Substantially Equivalent	Osypka Medical, Inc.
K081035	AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2	May 30, 2008	Substantially Equivalent	Osypka Medical, Inc.
K060387	PHYSIOFLOW SYSTEM	Apr 10, 2008	Substantially Equivalent	Vasocom, Inc.
K070985	AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC	Feb 01, 2008	Substantially Equivalent	Osypka Medical, Inc.
K072662	CHEETAH RELIANT, CHEETAH ACTIVE	Jan 16, 2008	Substantially Equivalent	Cheetah Medical, Inc.
K070156	BIOZ DX HEMODYNAMIC MONITOR WITH PHILIPS 12-LEAD ECG, MODEL 5100	Sep 26, 2007	Substantially Equivalent	Cardiodynamics International Corp.
K070500	BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM, MODEL NICAS 2004 SLIM	Jul 16, 2007	Substantially Equivalent	Ni Medical
K051228	BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG	Jun 10, 2005	Substantially Equivalent	Cardiodynamics International Corp.
K041294	BIOZDX HEMODYNAMIC MONITOR	Dec 08, 2004	Substantially Equivalent	Cardiodynamics International Corp.
K042113	ZOE FLUID STATUS MONITOR	Sep 14, 2004	Substantially Equivalent	Noninvasive Medical Technologies, LLC
K041434	C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS	Aug 06, 2004	Substantially Equivalent	Analogic Corp.
K032491	ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR	Sep 04, 2003	Unknown	Imagyn Medical Technologies, Inc.
K021174	ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR	Apr 29, 2003	Unknown	Imagyn Surgical
K014063	TASK FORCE MONITOR 3040	Feb 07, 2002	Substantially Equivalent	Cnsystems Medizintechnik GmbH
K014299	SORBA STEORRA NON-INVASIVE IMPEDANCE CARDIOGRAPH	Jan 30, 2002	Substantially Equivalent	Sorba Medical Systems, Inc.
K011439	MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR	Nov 02, 2001	Substantially Equivalent	Cardiodynamics International Corp.
K011797	BIOZTECT SENSOR AND BIOZTECT CABLE	Jul 03, 2001	Substantially Equivalent	Cardiodynamics International Corp.
K010164	ICG MODULE	Apr 09, 2001	Substantially Equivalent	General Electric Medical Systems Information Techn
K001081	BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810	Jun 30, 2000	Substantially Equivalent	Cardiodynamics International Corp.
K001100	BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE IMPEDANCE PLETHYSMOGRAPH	May 05, 2000	Substantially Equivalent	Cardiodynamics International Corp.
K981720	IQ SYSTEM	Feb 08, 1999	Substantially Equivalent	Renaissance Technology, Inc.
K974725	BIOZ.COM SYSTEM	Mar 18, 1998	Substantially Equivalent	Cardiodynamics International Corp.
K974621	PERCUPUMP II WITH EDA	Jan 27, 1998	Substantially Equivalent	E-Z-Em, Inc.
K962783	EDEMA SYSTEM	Oct 23, 1997	Substantially Equivalent	Bioanalogics, Inc.
K972320	BIOZ SYSTEM & BIOZ PORTABLE	Sep 11, 1997	Substantially Equivalent	Cardiodynamics International Corp.
K952172	HOTMAN	Jun 10, 1997	Substantially Equivalent	Hemo Sapiens, Inc.
K970603	D SERIES ELECTRODE	Apr 01, 1997	Substantially Equivalent	Cmc Sense-It, Inc.
K961845	PERCUPUMP II WITH EDA	Jan 23, 1997	Substantially Equivalent	E-Z-Em, Inc.
K963183	BIOZ SYSTEM	Nov 26, 1996	Substantially Equivalent	Cardiodynamics International Corp.
K942227	NICAS 2001 NONINVASIVE CARDIO-RESPIRATORY SYSTEM	Jun 28, 1996	Substantially Equivalent	C.L. Mcintosh & Assoc., Inc.
K922601	FUTREX-5000A	Dec 28, 1995	Substantially Equivalent	Futrex, Inc.
K922600	FUTREX-5000	Dec 28, 1995	Substantially Equivalent	Futrex, Inc.
K951097	BODYSTAY	Nov 22, 1995	Substantially Equivalent	Bodystat , Ltd.
K950389	SORBA MODEL CIC-1000 NON-INVASIVE HEMODYNAMIC MONITOR	Aug 15, 1995	Substantially Equivalent	Sorba Medical Systems, Inc.
K941162	HYPERGRAPH	Dec 15, 1994	Substantially Equivalent	Dermed Diagnostics, Inc.
K930599	BODY FAT ANALYZER MODEL TBF-105	Nov 01, 1994	Substantially Equivalent	Tanita Corp. of America
K932438	MODEL IPM-1 IMPEDANCE PULSE MONITOR	Dec 03, 1993	Substantially Equivalent	Electro-Diagnostic Instruments
K910994	MODIFIED SEISMOCARDIOGRAPH	Jan 15, 1992	Substantially Equivalent	Seismed Instruments, Inc.
K914200	VASCUMAP MEDICAL AIR PLETHYSMOGRAPH	Nov 07, 1991	Substantially Equivalent	Carolina Medical Electronics
K911194	IMPEDANCE PHLEBOGRAPH/PHOTOPLETHYSMOGRAPH-DVT-2000	Sep 30, 1991	Substantially Equivalent	Rjl Systems, Inc.
K904970	BODY COMPOSITION ANALYZER	Mar 07, 1991	Substantially Equivalent	Body Composition Analog, Inc.
K903700	IPG-II MODULE	Jan 16, 1991	Substantially Equivalent	Life Sciences Manufacturing, Inc.
K904109	BIO-IMPEDANCE ANALYZER	Jan 08, 1991	Substantially Equivalent	Xitron Technologies, Inc.
K902042	EM-SCAN HP-2 PEDIATRIC BODY COMPOSITION ANALYZER	Jul 26, 1990	Substantially Equivalent	Em-Scan, Inc.
K900213	PACEMAKER PATIENT ADAPTOR MODULE (PPAM)	Jun 28, 1990	Substantially Equivalent	Bomed Medical Mfg., Ltd.
K900321	DYNATRON 330 BODY COMPOSITION ANALYZER	Jun 11, 1990	Substantially Equivalent	Dynatronics Laser Corp.
K900130	MODIFIED SEISMOCARDIOGRAPH	Mar 28, 1990	Substantially Equivalent	Seismed Instruments, Inc.
K895588	PORTABLE AIR PLETHYSMOGRAPH	Mar 27, 1990	Substantially Equivalent	Life Sciences Manufacturing, Inc.
K896034	PROCORD MD3500 VASCULAR DIAGNOSTIC SYSTEM	Jan 18, 1990	Substantially Equivalent	D. E. Hokanson, Inc.
K892323	SEISMOCARDIOGRAPH - SCG(TM) 1000 SERIES	Oct 30, 1989	Substantially Equivalent	Seismed Instruments, Inc.
K894892	HD-2200 PNEUMO-DOP VASCULAR TESTING SYSTEM	Oct 27, 1989	Substantially Equivalent	Koven and Assoc., Inc.
K891928	HOLTAIN BODY COMPOSITION ANALYSER	Sep 22, 1989	Substantially Equivalent	Seritex, Inc.
K893963	VERIPOID 50 BIO-ELECTRICAL IMPEDANCE METER	Sep 05, 1989	Substantially Equivalent	V.S.B.B. Technologies, Inc.
K890408	ADDITIONAL SOFTWARE TO CARDIODYNAMIC MONITOR	Jun 01, 1989	Substantially Equivalent	Bomed Medical Mfg., Ltd.
K883919	NAPARIMA BIORESISTANCE METER & BODY COMP. ANALYZER	Dec 16, 1988	Substantially Equivalent	Naparima, Inc.
K881841	DANNINGER TRIMCHECK(TM) PORTABLE & DESK TOP MODELS	Dec 13, 1988	Substantially Equivalent	Buckman Co., Inc.
K884033	BIODYNAMICS MODEL 200 BODY COMPOSITION ANALYZER	Nov 17, 1988	Substantially Equivalent	Biodynamics Corp.
K881291	AIR PLETHYSMOGRAPH MODEL APG-1000	Oct 14, 1988	Substantially Equivalent	Aci Medical, Inc.
K881851	VERIPOID 50 BIO-ELECTRICAL IMPEDANCE METER	Sep 26, 1988	Substantially Equivalent	Micro Medical, Ltd.
K881968	BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER	Jul 28, 1988	Substantially Equivalent	Biodynamics Corp.
K874938	PERIPHERAL VASCULAR LABORATORY ASSISTANT MODEL 101	Jul 12, 1988	Substantially Equivalent	Sp Innovations, Inc.
K880926	BIOLOGICAL OHM METER, BES 200Z	Jun 15, 1988	Substantially Equivalent	Bioelectrical Sciences, Inc.
K874361	BIODYNAMICS MODEL BI-300 BODY COMPOSITION ANALYZER	Mar 16, 1988	Substantially Equivalent	Biodynamics Corp.
K871040	CONSULTANT BODY COMPOSITION ANALYZER	Jun 05, 1987	Substantially Equivalent	Body Composition Analog, Inc.
K863833	BODY WATCH BODY COMPOSITION ANALYZER MODEL 2010	Mar 17, 1987	Substantially Equivalent	Body Watch, Inc.
K864889	OMNI-TRAK	Mar 06, 1987	Substantially Equivalent	Invivo Research Labs, Inc.
K862383	MODIFIED MODEL BIA-103 BODY COMPOSITION ANALYZER	Feb 03, 1987	Substantially Equivalent	Rjl Systems, Inc.
K861205	1990A BIO-RESISTANCE BODY COMPOSITION ANALYZER	Jan 05, 1987	Substantially Equivalent	Valhalla Scientific
K862714	BILATERAL IMPEDANCE PLETHYSMOGRAPH, BIP(TM)	Nov 17, 1986	Substantially Equivalent	Electro-Diagnostic Instruments
K860749	HA-2 HUMAN BODY COMPOSITION ANALYZER	Sep 02, 1986	Substantially Equivalent	Dj Medical Instrument Corp. C/O Keller & Heckman
K853706	BOMED-CDM	Apr 14, 1986	Substantially Equivalent	Bomed Medical Mfr., Ltd.
K852238	IPG-300	Oct 11, 1985	Substantially Equivalent	Thornton Associates, Inc.
K851415	BODY ANALYSIS SYSTEM (DEEMED SE 87/09/18)	Jul 08, 1985	Substantially Equivalent	Medi-Sport Testing, Inc.
K852378	LIGHT REFLECTION RHEOGRAPHY	Jun 20, 1985	Substantially Equivalent	Hemodynamics, Inc.
K833728	CARDIAC WALL MOTION DEVICE	Feb 10, 1984	Substantially Equivalent	Intl. Medical, Inc.
K833155	RAYDEN MEDICAL MINI PULSE VOLUME RECORD	Jan 26, 1984	Substantially Equivalent	Burditt & Calkins-Siemens-Elema
K831422	BIOFLOW	Sep 12, 1983	Substantially Equivalent	Bomed Medical Mfr., Ltd.
K831421	BOMED BIOCON	Sep 12, 1983	Substantially Equivalent	Bomed Medical Mfr., Ltd.
K830292	BIOELECTRICAL IMPEDANCE ANALYZER #101	Aug 12, 1983	Substantially Equivalent	Rjl Systems, Inc.
K823215	CKG 8800	Nov 24, 1982	Substantially Equivalent	Cardio Kinetics, Inc.
K822522	CUTANEOUS PRESSURE PLETHYSMOGRAPH	Sep 28, 1982	Substantially Equivalent	Life Sciences Manufacturing, Inc.
K822455	VASOGRAPH, MODEL MV-2	Sep 24, 1982	Substantially Equivalent	Electro-Diagnostic Instruments
K822020	CKG 8000	Aug 06, 1982	Substantially Equivalent	Cardio Kinetics, Inc.
K820959	BLOOD FLOW ANALYZER	May 25, 1982	Substantially Equivalent	Biofax Medical Instrumentation Co.
K811999	BO MED BIA	Aug 31, 1981	Substantially Equivalent	Bomed Medical Mfr., Ltd.
K792051	CKG CARDIOKYMOGRAPH	Nov 13, 1979	Substantially Equivalent	Cardio Kinetics, Inc.
K781352	STRAIN GAUGE PLETHYSMOGRAPH	Oct 27, 1978	Substantially Equivalent	Medimatic
K772092	CHEST FLUID MONITOR	Nov 18, 1977	Substantially Equivalent	Dynatech Research & Development Co.