FDA Product Code OBH: Monitor, Extracellular Fluid, Lymphedema, Extremity
Measure Impedances In Affected And Unaffected But Opposite Extremity To Periodically Monitor The Level Of Extracellular Fluid Or The Differences In Bioimpedance Between Opposing Extremities For Patients Who Have Been Previously Diagnosed With Unilateral Lymphedema (that Is, In One Affected Extremity)
Leading manufacturers include ImpediMed Limited and Delfin Technologies, Ltd..
10
Total
10
Cleared
242d
Avg days
2007
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg
121d
recently vs 256d historically
FDA 510(k) Cleared Monitor, Extracellular Fluid, Lymphedema, Extremity Devices (Product Code OBH)
10 devices
Cleared
Jan 28, 2026
MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)
ImpediMed Limited
Gastroenterology & Urology
121d
Cleared
May 04, 2023
SOZO Pro
ImpediMed Limited
Gastroenterology & Urology
66d
Cleared
May 27, 2022
MoistureMeterD Compact, LymphScanner
Delfin Technologies, Ltd.
Gastroenterology & Urology
88d
Cleared
Apr 16, 2018
SOZO
ImpediMed Limited
Gastroenterology & Urology
90d
About Product Code OBH - Regulatory Context
510(k) Submission Activity
10 total 510(k) submissions under product code OBH since 2007, with 10 receiving FDA clearance (average review time: 242 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA 510(k) Review Time - OBH Product Code
Recent submissions under OBH have taken an average of 121 days to reach a decision - down from 256 days historically, suggesting improved FDA processing for this classification.
OBH devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →