Cleared Traditional

IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400 (K080825) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K080825 · Impedimed Pty , Ltd. · Gastroenterology & Urology device
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Oct 2008
Decision
193d
Days
Class 2
Risk

K080825 is an FDA 510(k) clearance for the IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400. Classified as Monitor, Extracellular Fluid, Lymphedema, Extremity (product code OBH), Class II - Special Controls.

Submitted by Impedimed Pty , Ltd. (Pinkenba, Qld, AU). The FDA issued a Cleared decision on October 3, 2008 after a review of 193 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 870.2770 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K080825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received March 24, 2008
Decision Date October 03, 2008
Days to Decision 193 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 130d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OBH Monitor, Extracellular Fluid, Lymphedema, Extremity
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2770
Definition 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)
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.