510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K100811Substantially Equivalent

Impedimed - Extracellular Fluid Analyzer Model: L-Dex U400

Impedimed, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100811 is the FDA 510(k) clearance record for IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400, a class II device, cleared for ImpediMed Limited on under FDA product code OBH (Monitor, Extracellular Fluid, Lymphedema, Extremity). FDA's definition for product code OBH reads: "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...". FDA records list 16 510(k) clearances for ImpediMed Limited, from to . As of , FDA records show no recalls naming K100811.

Clearance record

Decision date
Received
(592 days to decision)
Product code
OBH Monitor, Extracellular Fluid, Lymphedema, Extremity
Regulation
21 CFR 870.2770
Device class
Class II
Review panel
Cardiovascular
Applicant
ImpediMed Limited 5959 Cornerstone Ct., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OBH

Trailing 12 months
1 clearance under product code OBH in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OBH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260