Cleared Traditional

IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS (K050415) - FDA 510(k) Clearance

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

K050415 · Impedimed Pty , Ltd. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Mar 2007
Decision
770d
Days
Class 2
Risk

K050415 is an FDA 510(k) clearance for the IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS. Classified as Monitor, Extracellular Fluid, Lymphedema, Extremity (product code OBH), Class II - Special Controls.

Submitted by Impedimed Pty , Ltd. (Brisbane, Queensland, AU). The FDA issued a Cleared decision on March 30, 2007 after a review of 770 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.

View all Impedimed Pty , Ltd. devices

Submission Details

510(k) Number K050415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received February 18, 2005
Decision Date March 30, 2007
Days to Decision 770 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
640d slower than avg
Panel avg: 130d · This submission: 770d
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.