Cleared Special

K013550 - CLIRANS E-SERIES DIALYZER

K013550 is an FDA 510(k) clearance for CLIRANS E-SERIES DIALYZER, manufactured by Terumo Medical Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Special 510(k) pathway after a 27-day FDA review.

K013550 · Terumo Medical Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
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Nov 2001
Decision
27d
Days
Class 2
Risk

K013550 is an FDA 510(k) clearance for the CLIRANS E-SERIES DIALYZER. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on November 20, 2001 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5860 - 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 Terumo Medical Corp. devices

FDA 510(k) Submission Details - K013550

510(k) Number K013550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2001
Decision Date November 20, 2001
Days to Decision 27 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 130d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

KDI Device Classification - Class 2, Special Controls

Product Code KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5860
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 - KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

All 226
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K013550.
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MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM
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GAMBRO POLYFLUX 6L, GAMBRO POLYFLUX 8L, GAMBRO POLYFLUX 10L, MODEL 6L, 8L, 10L
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