Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DSB · Predicate Candidate Screening
114 FDA 510(k) clearances under this product code; the 50 most recent screened below.
132 daysmedian FDA review time
371 days90th percentile
114clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250634 | BCM2-Body Composition Monitor | Fresenius Medical Care Renal Therapies Group, LLC | 2025-11-24 | 266 | 0 |
| K243727 | Re:Balans | Mode Sensors AS | 2025-10-16 | 317 | 0 |
| K250922 | Edema Guard Monitor (EGM) CardioSet-001 | Cardioset Medical , Ltd. | 2025-09-09 | 166 | 0 |
| K232089 | SOZO Pro | ImpediMed Limited | 2023-10-17 | 96 | 0 |
| K223217 | Zynex Monitoring System, Model CM-1600 | Zynex Medical, Inc. | 2023-06-16 | 242 | 0 |
| K211585 | Bodyport Cardiac Scale | Bodyport, Inc. | 2022-07-29 | 431 | 0 |
| K203473 | SOZO | ImpediMed Limited | 2021-04-19 | 145 | 0 |
| K193410 | SOZO Body Fluid Analyzer | ImpediMed Limited | 2020-10-02 | 298 | 0 |
| K191697 | Cardiac Monitor 1500 | Zynex Medical, Inc. | 2020-02-21 | 241 | 0 |
| K180479 | ReDS System | Sensible Medical Innovations , Ltd. | 2019-02-28 | 371 | 0 |
| K172431 | Cardiovascular Analzyer | Physiowave, Inc. | 2018-03-14 | 215 | 0 |
| K172507 | SOZO | ImpediMed Limited | 2017-12-22 | 126 | 0 |
| K172196 | ECOM™ Cardiac Output Monitoring System | Ecom Medical, Inc. | 2017-09-19 | 60 | 0 |
| K150095 | ReDs Wearable System | Sensible Medical Innovations , Ltd. | 2015-08-06 | 202 | 0 |
| K142503 | IMED-Z FLUID STATUS MONITOR | Intersection Medical, Inc. | 2015-06-05 | 273 | 0 |
| K140102 | PHYSIOFLOW Q-LINK | Vasocom, Inc. | 2014-02-12 | 28 | 0 |
| K133301 | ZOE FLUID STATUS MONITOR | Noninvasive Medical Technologies, Inc. | 2014-01-22 | 89 | 0 |
| K131765 | ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM | Conmed Corporation | 2013-12-20 | 186 | 0 |
| K131509 | ZOE FLUID STATUS MONITOR | Noninvasive Medical Technologies, Inc. | 2013-06-28 | 35 | 0 |
| K112830 | ZOEFLUID STATUS MONITOR (MODEL ZOE 2B) | Noninvasive Medical Technologies, Inc. | 2012-11-13 | 412 | 0 |
| K110645 | BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR | Sonosite,Inc. | 2011-06-03 | 91 | 0 |
| K103166 | CHEETAH RELIANT | Cheetah Medical, Inc. | 2011-01-25 | 90 | 0 |
| K103283 | PHYSIOFLOW ENDURO | Vasocom, Inc. | 2010-12-03 | 28 | 0 |
| K080941 | BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM | N.I. Medical, Ltd. | 2009-06-18 | 441 | 0 |
| K090602 | CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS | Cardiodynamics International Corp. | 2009-05-28 | 84 | 0 |
| K083093 | CHEETAH RELIANT | Cheetah Medical, Inc. | 2008-12-15 | 59 | 1 |
| K082242 | ICON, MODEL C3 | Osypka Medical, Inc. | 2008-10-08 | 62 | 0 |
| K081035 | AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION C | Osypka Medical, Inc. | 2008-05-30 | 49 | 0 |
| K060387 | PHYSIOFLOW SYSTEM | Vasocom, Inc. | 2008-04-10 | 786 | 0 |
| K070985 | AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC | Osypka Medical, Inc. | 2008-02-01 | 301 | 0 |
| K072662 | CHEETAH RELIANT, CHEETAH ACTIVE | Cheetah Medical, Inc. | 2008-01-16 | 117 | 0 |
| K070156 | BIOZ DX HEMODYNAMIC MONITOR WITH PHILIPS 12-LEAD ECG, MODEL | Cardiodynamics International Corp. | 2007-09-26 | 252 | 0 |
| K070500 | BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM, MODEL NICAS | Ni Medical | 2007-07-16 | 145 | 0 |
| K051228 | BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG | Cardiodynamics International Corp. | 2005-06-10 | 28 | 0 |
| K041294 | BIOZDX HEMODYNAMIC MONITOR | Cardiodynamics International Corp. | 2004-12-08 | 208 | 0 |
| K042113 | ZOE FLUID STATUS MONITOR | Noninvasive Medical Technologies, LLC | 2004-09-14 | 40 | 0 |
| K041434 | C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS | Analogic Corp. | 2004-08-06 | 70 | 0 |
| K032491 | ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR | Imagyn Medical Technologies, Inc. | 2003-09-04 | 23 | 0 |
| K021174 | ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR | Imagyn Surgical | 2003-04-29 | 382 | 0 |
| K014063 | TASK FORCE MONITOR 3040 | Cnsystems Medizintechnik GmbH | 2002-02-07 | 58 | 1 |
| K014299 | SORBA STEORRA NON-INVASIVE IMPEDANCE CARDIOGRAPH | Sorba Medical Systems, Inc. | 2002-01-30 | 30 | 0 |
| K011439 | MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR | Cardiodynamics International Corp. | 2001-11-02 | 176 | 0 |
| K011797 | BIOZTECT SENSOR AND BIOZTECT CABLE | Cardiodynamics International Corp. | 2001-07-03 | 25 | 0 |
| K010164 | ICG MODULE | General Electric Medical Systems Information Techn | 2001-04-09 | 81 | 0 |
| K001081 | BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USE | Cardiodynamics International Corp. | 2000-06-30 | 87 | 0 |
| K001100 | BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ | Cardiodynamics International Corp. | 2000-05-05 | 30 | 0 |
| K981720 | IQ SYSTEM | Renaissance Technology, Inc. | 1999-02-08 | 279 | 0 |
| K974725 | BIOZ.COM SYSTEM | Cardiodynamics International Corp. | 1998-03-18 | 90 | 0 |
| K974621 | PERCUPUMP II WITH EDA | E-Z-Em, Inc. | 1998-01-27 | 47 | 0 |
| K962783 | EDEMA SYSTEM | Bioanalogics, Inc. | 1997-10-23 | 463 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda