Cleared Special

K250891 - Cure Catheter Insertion Kit (K1) (FDA 510(k) Clearance)

Also includes:
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

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

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

Submission Details

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.

Device Classification

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.