Cleared Traditional

K955762 - PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM (FDA 510(k) Clearance)

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

K955762 · Fresenius USA, Inc. · Gastroenterology & Urology device
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Jul 1996
Decision
226d
Days
Class 2
Risk

K955762 is an FDA 510(k) clearance for the PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM. Classified as System, Dialysate Delivery, Semi-automatic, Peritoneal (product code KPF), Class II - Special Controls.

Submitted by Fresenius USA, Inc. (Walnut Creek, US). The FDA issued a Cleared decision on July 31, 1996 after a review of 226 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5630 - 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 K955762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1995
Decision Date July 31, 1996
Days to Decision 226 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 130d · This submission: 226d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPF System, Dialysate Delivery, Semi-automatic, Peritoneal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5630
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.