Cleared Special

K082758 - PRISMAFLO II

K082758 is an FDA 510(k) clearance for PRISMAFLO II, manufactured by Stihler Electronic GmbH. The device is a Class 2 Gastroenterology & Urology device with product code KOC cleared through the Special 510(k) pathway after a 91-day FDA review.

K082758 · Stihler Electronic GmbH · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
91d
Days
Class 2
Risk

K082758 is an FDA 510(k) clearance for the PRISMAFLO II. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Stihler Electronic GmbH (Sound Beach, US). The FDA issued a Cleared decision on December 19, 2008 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - 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.

FDA 510(k) Submission Details - K082758

510(k) Number K082758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2008
Decision Date December 19, 2008
Days to Decision 91 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
40d faster than avg
Panel avg: 131d · This submission: 91d
Pathway characteristics
Modification to existing cleared device.

KOC Device Classification - Class 2, Special Controls

Product Code KOC Accessories, Blood Circuit, Hemodialysis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 - KOC Accessories, Blood Circuit, Hemodialysis

All 181
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K082758 · PRISMAFLO II
Download PDF FDA Summary Stihler Electronic Gm…