DSB · Class II · 21 CFR 870.2770

FDA Product Code DSB: Plethysmograph, Impedance

Leading manufacturers include Cardiodynamics International Corp., ImpediMed Limited and Vasocom, Inc..

115
Total
115
Cleared
188d
Avg days
1977
Since
Growing category - 4 submissions in the last 2 years vs 2 in the prior period
Review times increasing: avg 238d recently vs 186d historically

FDA 510(k) Cleared Plethysmograph, Impedance Devices (Product Code DSB)

115 devices
1–24 of 115
Cleared Aug 17, 2026
MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)
K260224
ImpediMed Limited
Gastroenterology & Urology · 203d
Cleared Nov 24, 2025
BCM2-Body Composition Monitor
K250634
Fresenius Medical Care Renal Therapies Group, LLC
Gastroenterology & Urology · 266d
Cleared Oct 16, 2025
Re:Balans
K243727
Mode Sensors AS
Cardiovascular · 317d
Cleared Sep 09, 2025
Edema Guard Monitor (EGM) CardioSet-001
K250922
Cardioset Medical , Ltd.
Cardiovascular · 166d
Cleared Oct 17, 2023
SOZO Pro
K232089
ImpediMed Limited
Gastroenterology & Urology · 96d
Cleared Jun 16, 2023
Zynex Monitoring System, Model CM-1600
K223217
Zynex Medical, Inc.
Cardiovascular · 242d
Cleared Jul 29, 2022
Bodyport Cardiac Scale
K211585
Bodyport, Inc.
Cardiovascular · 431d
Cleared Apr 19, 2021
SOZO
K203473
ImpediMed Limited
Gastroenterology & Urology · 145d
Cleared Oct 02, 2020
SOZO Body Fluid Analyzer
K193410
ImpediMed Limited
Gastroenterology & Urology · 298d
Cleared Feb 21, 2020
Cardiac Monitor 1500
K191697
Zynex Medical, Inc.
Cardiovascular · 241d
Cleared Feb 28, 2019
ReDS System
K180479
Sensible Medical Innovations , Ltd.
Cardiovascular · 371d
Cleared Mar 14, 2018
Cardiovascular Analzyer
K172431
Physiowave, Inc.
Cardiovascular · 215d
Cleared Dec 22, 2017
SOZO
K172507
ImpediMed Limited
Cardiovascular · 126d
Cleared Sep 19, 2017
ECOM™ Cardiac Output Monitoring System
K172196
Ecom Medical, Inc.
Cardiovascular · 60d
Cleared Aug 06, 2015
ReDs Wearable System
K150095
Sensible Medical Innovations , Ltd.
Cardiovascular · 202d
Cleared Jun 05, 2015
IMED-Z FLUID STATUS MONITOR
K142503
Intersection Medical, Inc.
Cardiovascular · 273d
Cleared Feb 12, 2014
PHYSIOFLOW Q-LINK
K140102
Vasocom, Inc.
Cardiovascular · 28d
Cleared Jan 22, 2014
ZOE FLUID STATUS MONITOR
K133301
Noninvasive Medical Technologies, Inc.
Cardiovascular · 89d
Cleared Dec 20, 2013
ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM
K131765
Conmed Corporation
Cardiovascular · 186d
Cleared Jun 28, 2013
ZOE FLUID STATUS MONITOR
K131509
Noninvasive Medical Technologies, Inc.
Cardiovascular · 35d
Cleared Nov 13, 2012
ZOEFLUID STATUS MONITOR (MODEL ZOE 2B)
K112830
Noninvasive Medical Technologies, Inc.
Cardiovascular · 412d
Cleared Jun 03, 2011
BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR
K110645
Sonosite,Inc.
Cardiovascular · 91d
Cleared Dec 03, 2010
PHYSIOFLOW ENDURO
K103283
Vasocom, Inc.
Cardiovascular · 28d
Cleared Apr 10, 2008
PHYSIOFLOW SYSTEM
K060387
Vasocom, Inc.
Cardiovascular · 786d

About Product Code DSB - Regulatory Context

510(k) Submission Activity

115 total 510(k) submissions under product code DSB since 1977, with 115 receiving FDA clearance (average review time: 188 days).

Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - DSB Product Code

Recent submissions under DSB have taken an average of 238 days to reach a decision - up from 186 days historically. Manufacturers should account for longer review timelines in current project planning.

DSB devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →