Cleared Special

K182144 - Bi-Flex Evo

K182144 is an FDA 510(k) clearance for Bi-Flex Evo, manufactured by Promepla Sam. The device is a Class 2 Gastroenterology & Urology device with product code KNY cleared through the Special 510(k) pathway after a 30-day FDA review.

K182144 · Promepla Sam · Gastroenterology & Urology device
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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.

View all Promepla Sam devices

FDA 510(k) Submission Details - K182144

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 131d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

KNY Device Classification - Class 2, Special Controls

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.

Regulatory Peers - KNY Accessories, Catheter, G-u

All 41
Devices cleared under the same product code (KNY) and FDA review panel - the closest regulatory comparables to K182144.
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K140562 · Leomed, LLC · Jun 2014
GUARDIAN URETHRAL SHEATH
K141252 · Solace Therapeutics · Jun 2014
GUARDIAN URETHRAL SHEATH
K131803 · Solace Therapeutics · Aug 2013