Cleared Special

K082758 - PRISMAFLO II

K082758 is the FDA 510(k) clearance for PRISMAFLO II by Stihler Electronic GmbH. It is a Class 2 Gastroenterology & Urology device (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)
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.

View all Stihler Electronic GmbH devices

Submission Details

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
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 130d · This submission: 91d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 113
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K082758.
CRIT-LINE CLIP (CLIC) BLOOD CHAMBER
K152953 · Fresenius Medical Care North America · Nov 2015
CRIT-LINE CLIP (CLIC) BLOOD CHAMBER
K141281 · Fresenius Medical Care Renal Therapies Group, LLC · Aug 2014
CRIT-LINE CLIP (CLIC)
K121599 · Fresenius Medical Care North America · Nov 2012
LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT
K081043 · Nxstage Medical, Inc. · Jul 2008
FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9
K010268 · Fresenius Medical Care North America · Apr 2001
ARTERIAL BLOOD TUBING SET FOR SINGLE NEEDLE HEMODIALYSIS
K955277 · Baxter Healthcare Corp · Feb 1996