Not Cleared Direct

DEN180055 - CARPEDIEM System (FDA 510(k) Clearance)

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

DEN180055 · Bellco Srl (Now Part of Medtronic, Inc) · Gastroenterology & Urology device
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Apr 2020
Decision
568d
Days
Class 2
Risk

DEN180055 is an FDA 510(k) submission (not cleared) for the CARPEDIEM System. Classified as Pediatric Hemodialysis System (product code QIR), Class II - Special Controls.

Submitted by Bellco Srl (Now Part of Medtronic, Inc) (Mirandola, IT). The FDA issued a Not Cleared (DENG) decision on April 29, 2020 after a review of 568 days.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5861 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 568 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Bellco Srl (Now Part of Medtronic, Inc) devices

Submission Details

510(k) Number DEN180055 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received October 09, 2018
Decision Date April 29, 2020
Days to Decision 568 days
Submission Type Direct
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
438d slower than avg
Panel avg: 130d · This submission: 568d
Pathway characteristics

Device Classification

Product Code QIR Pediatric Hemodialysis System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5861
Definition For Use In Acute Kidney Injury Or Fluid Overloaded Patients Requiring Hemodialysis Or Hemofiltration Therapy. It Is Intended To Provide Continuous Renal Replacement Therapy (crrt) To Patients Weighing Between 2.5 And 10 Kilograms.
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.