Cleared Special

K121421 - FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT) (FDA 510(k) Clearance)

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

K121421 · Fresenius Medical Care North America, Design Cente · Gastroenterology & Urology device
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Jan 2013
Decision
248d
Days
Class 2
Risk

K121421 is an FDA 510(k) clearance for the FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WET.... Classified as Hemodialysis System For Home Use (product code ONW), Class II - Special Controls.

Submitted by Fresenius Medical Care North America, Design Cente (Waltham, US). The FDA issued a Cleared decision on January 17, 2013 after a review of 248 days - an extended review 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Fresenius Medical Care North America, Design Cente devices

Submission Details

510(k) Number K121421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2012
Decision Date January 17, 2013
Days to Decision 248 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d slower than avg
Panel avg: 130d · This submission: 248d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code ONW Hemodialysis System For Home Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5860
Definition To Treat And Provide Hemodialysis Therapy At Home For Chronic Renal Failure Patients.
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.