Cleared Traditional

K170150 - Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags (FDA 510(k) Clearance)

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

K170150 · S.A.L.F. Spa · Gastroenterology & Urology device
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Oct 2017
Decision
276d
Days
Class 2
Risk

K170150 is an FDA 510(k) clearance for the Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000.... Classified as Set, Perfusion, Kidney, Disposable (product code KDL), Class II - Special Controls.

Submitted by S.A.L.F. Spa (Cenate Sotto, IT). The FDA issued a Cleared decision on October 20, 2017 after a review of 276 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5880 - 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.

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Submission Details

510(k) Number K170150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2017
Decision Date October 20, 2017
Days to Decision 276 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
146d slower than avg
Panel avg: 130d · This submission: 276d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KDL Set, Perfusion, Kidney, Disposable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5880
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.