Cleared Traditional

K253224 - MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) (FDA 510(k) Clearance)

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

K253224 · ImpediMed Limited · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2026
Decision
121d
Days
Class 2
Risk

K253224 is an FDA 510(k) clearance for the MySOZO Software version 6.0.1.2 (SW version 6.0.1.2). Classified as Monitor, Extracellular Fluid, Lymphedema, Extremity (product code OBH), Class II - Special Controls.

Submitted by ImpediMed Limited (Pinkenba, AU). The FDA issued a Cleared decision on January 28, 2026 after a review of 121 days - within the typical 510(k) review window.

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.

View all ImpediMed Limited devices

Submission Details

510(k) Number K253224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2025
Decision Date January 28, 2026
Days to Decision 121 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 130d · This submission: 121d
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.