Cleared Traditional

K913515 - TOTAL CONTAINMENT DEVICE

K913515 is an FDA 510(k) clearance for TOTAL CONTAINMENT DEVICE, manufactured by Denco. The device is a Class 2 Gastroenterology & Urology device with product code KPF cleared through the Traditional 510(k) pathway after a 1023-day FDA review.

K913515 · Denco · Gastroenterology & Urology device
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May 1994
Decision
1023d
Days
Class 2
Risk

K913515 is an FDA 510(k) clearance for the TOTAL CONTAINMENT DEVICE. Classified as System, Dialysate Delivery, Semi-automatic, Peritoneal (product code KPF), Class II - Special Controls.

Submitted by Denco (Wilmington, US). The FDA issued a Cleared decision on May 26, 1994 after a review of 1023 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Denco devices

FDA 510(k) Submission Details - K913515

510(k) Number K913515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1991
Decision Date May 26, 1994
Days to Decision 1023 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
893d slower than avg
Panel avg: 130d · This submission: 1023d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPF Device Classification - Class 2, Special Controls

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.

Regulatory Peers - KPF System, Dialysate Delivery, Semi-automatic, Peritoneal

All 8
Devices cleared under the same product code (KPF) and FDA review panel - the closest regulatory comparables to K913515.
RENALSOFT
K061515 · Baxter Healthcare Corp · Sep 2006
RENAL LINK
K990953 · Baxter Healthcare Corp · Jun 1999
PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM
K955762 · Fresenius USA, Inc. · Jul 1996
ULTRACARE(TM) AUTOMATED PATIENT ASSIST DEVICE
K874020 · Abbott Laboratories · Jan 1988
GAMBRO PERITONEAL DIALYSIS MONITOR
K802831 · Gambro, Inc. · Dec 1980
CYCLER W/5 OR 10 HR. FILL/DWELL TIMER
K800496 · American Medical Products, Inc. · Jul 1980