Cleared Special

K182144 - Bi-Flex Evo (FDA 510(k) Clearance)

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

K182144 · Promepla Sam · Gastroenterology & Urology device
Sep 2018
Decision
30d
Days
Class 2
Risk

K182144 is an FDA 510(k) clearance for the Bi-Flex Evo. Classified as Accessories, Catheter, G-u (product code KNY), Class II - Special Controls.

Submitted by Promepla Sam (Monaco, MC). The FDA issued a Cleared decision on September 7, 2018 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

Submission Details

510(k) Number K182144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2018
Decision Date September 07, 2018
Days to Decision 30 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
126d faster than avg
Panel avg: 156d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KNY Accessories, Catheter, G-u
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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.