Cleared Traditional

K070049 - FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR (FDA 510(k) Clearance)

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

K070049 · Fresenius Medical Care North America · Gastroenterology & Urology device
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Feb 2011
Decision
1491d
Days
Class 2
Risk

K070049 is an FDA 510(k) clearance for the FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR. Classified as Hemodialysis System For Home Use (product code ONW), Class II - Special Controls.

Submitted by Fresenius Medical Care North America (Waltham, US). The FDA issued a Cleared decision on February 3, 2011 after a review of 1491 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5860 - 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 Fresenius Medical Care North America devices

Submission Details

510(k) Number K070049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2007
Decision Date February 03, 2011
Days to Decision 1491 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1361d slower than avg
Panel avg: 130d · This submission: 1491d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.