Cleared Special

K172122 - SOZO (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K172122 · ImpediMed Limited · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
29d
Days
Class 2
Risk

K172122 is an FDA 510(k) clearance for the SOZO. 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 August 11, 2017 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 870.2770 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all ImpediMed Limited devices

Submission Details

510(k) Number K172122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2017
Decision Date August 11, 2017
Days to Decision 29 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 130d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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.