Cleared Abbreviated

K020103 - PRISMAFLO

K020103 is an FDA 510(k) clearance for PRISMAFLO, manufactured by Stihler Electronic GmbH. The device is a Class 2 Gastroenterology & Urology device with product code KOC cleared through the Abbreviated 510(k) pathway after a 194-day FDA review.

K020103 · Stihler Electronic GmbH · Gastroenterology & Urology device
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Jul 2002
Decision
194d
Days
Class 2
Risk

K020103 is an FDA 510(k) clearance for the PRISMAFLO. 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 July 24, 2002 after a review of 194 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - the FDA gastroenterology and urology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K020103

510(k) Number K020103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2002
Decision Date July 24, 2002
Days to Decision 194 days
Submission Type Abbreviated
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 131d · This submission: 194d
Pathway characteristics
Standards-based clearance path.

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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K020103 · PRISMAFLO
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