Cleared Special

K250891 - Cure Catheter Insertion Kit (K1)

Also marketed or referenced as:
Cure Catheter Insertion Kit (K2) Cure Catheter Insertion Kit (K2-90) Cure Catheter Insertion Kit (K3) Cure Hydrophilic Catheter Kit (HM12UK) Cure Hydrophilic Catheter Kit (HM14UK) Cure Hydrophilic Catheter Kit (HM16UK) Cure Pocket Catheter Kit (M14UK) Cure Catheter Closed System Kit (CS8) Cure Catheter Closed System Kit (CS10) Cure Catheter Closed System Kit (CS12) Cure Catheter Closed System Kit (CS14) Cure Catheter Closed System Kit (CS14C

K250891 is an FDA 510(k) clearance for Cure Catheter Insertion Kit (K1), manufactured by Convatec Limited. The device is a Class 2 Gastroenterology & Urology device with product code FCM cleared through the Special 510(k) pathway after a 73-day FDA review.

K250891 · Convatec Limited · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2025
Decision
73d
Days
Class 2
Risk

K250891 is an FDA 510(k) clearance for the Cure Catheter Insertion Kit (K1). Classified as Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) (product code FCM), Class II - Special Controls.

Submitted by Convatec Limited (Flintshire, GB). The FDA issued a Cleared decision on June 6, 2025 after a review of 73 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 Convatec Limited devices

FDA 510(k) Submission Details - K250891

510(k) Number K250891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received March 25, 2025
Decision Date June 06, 2025
Days to Decision 73 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
57d faster than avg
Panel avg: 130d · This submission: 73d
Pathway characteristics
Modification to existing cleared device.

FCM Device Classification - Class 2, Special Controls

Product Code FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)
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 - FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)

All 29
Devices cleared under the same product code (FCM) and FDA review panel - the closest regulatory comparables to K250891.
BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit
K254076 · C.R. Bard, Inc. · May 2026
Self-Cath Closed System
K223821 · Coloplast · Aug 2023
AMSELF CLOSED CATHETERIZATION SYSTEM
K082831 · Amsino International, Inc. · Oct 2008
AMSURE FOLEY INSERTION TRAY
K030664 · Amsino International, Inc. · May 2003
AMSURE URETHRAL CATHETERIZATION TRAY
K030712 · Amsino International, Inc. · May 2003
RUSCH MMG/O'NEIL CATHETER
K010420 · Rusch, Inc. · May 2001