Product code DSB— Cardiovascular
ZOE FLUID STATUS MONITOR
- Classification name
- Plethysmograph, Impedance
- Device class
- Class 2
- Regulation
- 21 CFR 870.2770
- Advisory panel
- Cardiovascular
- Total cleared
- 115
- First cleared
- Most recent
Market context for product code DSB
FDA has cleared devices under product code DSB between 1977 and 2026, filed by 71 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- 2026
- 2025
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2015
- 2014
- 2013
- 2012
- 2011
- 2010
Top applicants under product code DSB
Recent clearances under product code DSB
1–100 of 115- K260224 — MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)
- K250634 — BCM2-Body Composition Monitor
- K243727 — Re:Balans
- K250922 — Edema Guard Monitor (EGM) CardioSet-001
- K232089 — SOZO Pro
- K223217 — Zynex Monitoring System, Model CM-1600
- K211585 — Bodyport Cardiac Scale
- K203473 — SOZO
- K193410 — SOZO Body Fluid Analyzer
- K191697 — Cardiac Monitor 1500
- K180479 — ReDS System
- K172431 — Cardiovascular Analzyer
- K172507 — SOZO
- K172196 — ECOM Cardiac Output Monitoring System
- K150095 — ReDs Wearable System
- K142503 — IMED-Z FLUID STATUS MONITOR
- K140102 — PHYSIOFLOW Q-LINK
- K133301 — ZOE FLUID STATUS MONITOR
- K131765 — ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM
- K131509 — ZOE FLUID STATUS MONITOR
- K112830 — ZOEFLUID STATUS MONITOR (MODEL ZOE 2B)
- K110645 — BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR
- K103166 — CHEETAH RELIANT
- K103283 — PHYSIOFLOW ENDURO
- K080941 — BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM
- K090602 — CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS
- K083093 — CHEETAH RELIANT
- K082242 — ICON, MODEL C3
- K081035 — AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2
- K060387 — PHYSIOFLOW SYSTEM
- K070985 — AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC
- K072662 — CHEETAH RELIANT, CHEETAH ACTIVE
- K070156 — BIOZ DX HEMODYNAMIC MONITOR WITH PHILIPS 12-LEAD ECG, MODEL 5100
- K070500 — BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM, MODEL NICAS 2004 SLIM
- K051228 — BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG
- K041294 — BIOZDX HEMODYNAMIC MONITOR
- K042113 — ZOE FLUID STATUS MONITOR
- K041434 — C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS
- K032491 — ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR
- K021174 — ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR
- K014063 — TASK FORCE MONITOR 3040
- K014299 — SORBA STEORRA NON-INVASIVE IMPEDANCE CARDIOGRAPH
- K011439 — MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR
- K011797 — BIOZTECT SENSOR AND BIOZTECT CABLE
- K010164 — ICG MODULE
- K001081 — BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810
- K001100 — BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE IMPEDANCE PLETHYSMOGRAPH
- K981720 — IQ SYSTEM
- K974725 — BIOZ.COM SYSTEM
- K974621 — PERCUPUMP II WITH EDA
- K962783 — EDEMA SYSTEM
- K972320 — BIOZ SYSTEM & BIOZ PORTABLE
- K952172 — HOTMAN
- K970603 — D SERIES ELECTRODE
- K961845 — PERCUPUMP II WITH EDA
- K963183 — BIOZ SYSTEM
- K942227 — NICAS 2001 NONINVASIVE CARDIO-RESPIRATORY SYSTEM
- K922600 — FUTREX-5000
- K922601 — FUTREX-5000A
- K951097 — BODYSTAY
- K950389 — SORBA MODEL CIC-1000 NON-INVASIVE HEMODYNAMIC MONITOR
- K941162 — HYPERGRAPH
- K930599 — BODY FAT ANALYZER MODEL TBF-105
- K932438 — MODEL IPM-1 IMPEDANCE PULSE MONITOR
- K910994 — MODIFIED SEISMOCARDIOGRAPH
- K914200 — VASCUMAP MEDICAL AIR PLETHYSMOGRAPH
- K911194 — IMPEDANCE PHLEBOGRAPH/PHOTOPLETHYSMOGRAPH-DVT-2000
- K904970 — BODY COMPOSITION ANALYZER
- K903700 — IPG-II MODULE
- K904109 — BIO-IMPEDANCE ANALYZER
- K902042 — EM-SCAN HP-2 PEDIATRIC BODY COMPOSITION ANALYZER
- K900213 — PACEMAKER PATIENT ADAPTOR MODULE (PPAM)
- K900321 — DYNATRON 330 BODY COMPOSITION ANALYZER
- K900130 — MODIFIED SEISMOCARDIOGRAPH
- K895588 — PORTABLE AIR PLETHYSMOGRAPH
- K896034 — PROCORD MD3500 VASCULAR DIAGNOSTIC SYSTEM
- K892323 — SEISMOCARDIOGRAPH - SCG(TM) 1000 SERIES
- K894892 — HD-2200 PNEUMO-DOP VASCULAR TESTING SYSTEM
- K891928 — HOLTAIN BODY COMPOSITION ANALYSER
- K893963 — VERIPOID 50 BIO-ELECTRICAL IMPEDANCE METER
- K890408 — ADDITIONAL SOFTWARE TO CARDIODYNAMIC MONITOR
- K883919 — NAPARIMA BIORESISTANCE METER & BODY COMP. ANALYZER
- K881841 — DANNINGER TRIMCHECK(TM) PORTABLE & DESK TOP MODELS
- K884033 — BIODYNAMICS MODEL 200 BODY COMPOSITION ANALYZER
- K881291 — AIR PLETHYSMOGRAPH MODEL APG-1000
- K881851 — VERIPOID 50 BIO-ELECTRICAL IMPEDANCE METER
- K881968 — BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER
- K874938 — PERIPHERAL VASCULAR LABORATORY ASSISTANT MODEL 101
- K880926 — BIOLOGICAL OHM METER, BES 200Z
- K874361 — BIODYNAMICS MODEL BI-300 BODY COMPOSITION ANALYZER
- K871040 — CONSULTANT BODY COMPOSITION ANALYZER
- K863833 — BODY WATCH BODY COMPOSITION ANALYZER MODEL 2010
- K864889 — OMNI-TRAK
- K862383 — MODIFIED MODEL BIA-103 BODY COMPOSITION ANALYZER
- K861205 — 1990A BIO-RESISTANCE BODY COMPOSITION ANALYZER
- K862714 — BILATERAL IMPEDANCE PLETHYSMOGRAPH, BIP(TM)
- K860749 — HA-2 HUMAN BODY COMPOSITION ANALYZER
- K853706 — BOMED-CDM
- K852238 — IPG-300
- K851415 — BODY ANALYSIS SYSTEM (DEEMED SE 87/09/18)
Data sourced from openFDA. This site is unofficial and independent of the FDA.