Cleared Traditional

K260224 - MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)

K260224 is an FDA 510(k) clearance for MySOZO Software version 6.1.0.1 (SW ver..., manufactured by ImpediMed Limited. The device is a Class 2 Gastroenterology & Urology device with product code DSB cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K260224 · ImpediMed Limited · Gastroenterology & Urology device
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Aug 2026
Decision
203d
Days
Class 2
Risk

K260224 is an FDA 510(k) clearance for the MySOZO Software version 6.1.0.1 (SW version 6.1.0.1). Classified as Plethysmograph, Impedance (product code DSB), Class II - Special Controls.

Submitted by ImpediMed Limited (Lindfield, AU). The FDA issued a Cleared decision on August 17, 2026 after a review of 203 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.

View all ImpediMed Limited devices

FDA 510(k) Submission Details - K260224

510(k) Number K260224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2026
Decision Date August 17, 2026
Days to Decision 203 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
72d slower than avg
Panel avg: 131d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSB Device Classification - Class 2, Special Controls

Product Code DSB Plethysmograph, Impedance
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2770
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.

Regulatory Peers - DSB Plethysmograph, Impedance

All 43
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