DSB · Class II · 21 CFR 870.2770

FDA Product Code DSB: Plethysmograph, Impedance

Leading manufacturers include ImpediMed Limited, Zynex Medical, Inc. and E-Z-Em, Inc..

114
Total
114
Cleared
187d
Avg days
1977
Since
Growing category - 3 submissions in the last 2 years vs 2 in the prior period
Review times increasing: avg 250d recently vs 186d historically

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

114 devices
1–24 of 114
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 20, 2013
ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM
K131765
Conmed Corporation
Cardiovascular · 186d
Cleared Aug 06, 2004
C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS
K041434
Analogic Corp.
Cardiovascular · 70d
Cleared Apr 09, 2001
ICG MODULE
K010164
General Electric Medical Systems Information Techn
Cardiovascular · 81d
Cleared Jan 27, 1998
PERCUPUMP II WITH EDA
K974621
E-Z-Em, Inc.
Radiology · 47d
Cleared Jan 23, 1997
PERCUPUMP II WITH EDA
K961845
E-Z-Em, Inc.
Radiology · 255d
Cleared Dec 13, 1988
DANNINGER TRIMCHECK(TM) PORTABLE & DESK TOP MODELS
K881841
Buckman Co., Inc.
Cardiovascular · 225d

About Product Code DSB - Regulatory Context

510(k) Submission Activity

114 total 510(k) submissions under product code DSB since 1977, with 114 receiving FDA clearance (average review time: 187 days).

Submission volume has increased in recent years - 3 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 250 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 →