Cleared Traditional

K100811 - IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400 (FDA 510(k) Clearance)

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

K100811 · ImpediMed Limited · Gastroenterology & Urology device
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Nov 2011
Decision
592d
Days
Class 2
Risk

K100811 is an FDA 510(k) clearance for the IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400. Classified as Monitor, Extracellular Fluid, Lymphedema, Extremity (product code OBH), Class II - Special Controls.

Submitted by ImpediMed Limited (San Diego, US). The FDA issued a Cleared decision on November 4, 2011 after a review of 592 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

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Submission Details

510(k) Number K100811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2010
Decision Date November 04, 2011
Days to Decision 592 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
462d slower than avg
Panel avg: 130d · This submission: 592d
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.