Convatec Limited · Class II · Cleared Jun 6, 2025
| K-number | K250891 |
| Device name | Cure Catheter Insertion Kit (K1); 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 |
| Applicant | Convatec Limited |
| Product code | FCM |
| Device class | Class II |
| Decision date | Jun 6, 2025 |
| Decision | Unknown |
| Regulation | 876.5130 |
The Cure Catheter Insertion Kit is a sterile, single-use intermittent urinary catheter kit for bladder drainage in males and females. It comes in multiple configurations (K1, K2, K2-90, K3, hydrophilic variants, pocket variants, and closed system variants) with various component combinations including underpads, wipes, gloves, collection bags, lubricating gel, and catheters.
The subject device is a convenience kit containing underpads, BZK wipes, gloves, urine collection bags, PVP swabsticks, lubricating gel, and sterile wipes with a urinary catheter—identical core components to the predicate Cure Catheter Closed System. The kit configurations differ in specific contents (e.g., K3 lacks lubricating gel; hydrophilic kits include specialized catheters) but maintain the same fundamental design and functional purpose.
Sterilization validation per AAMI/ISO 11135-1:2014/AMD 1:2018 and ISO 10993-7:2008/AMD:2019; biocompatibility per ISO 10993-1:2018; sterile packaging per ISO 11607-1:2019 and ISO 11607-2:2019; shelf-life testing per ISO 11607-1:2006; packaging integrity per ASTM F2096-11 (2019); urinary catheter testing per ISO 20696:2018.
The subject and predicate devices share identical intended use (intermittent urinary catheterization for bladder drainage), same regulatory classification (21 CFR 876.5130), equivalent technological features (same component types and functions), equivalent biocompatibility test results, identical sterilization method (EO, SAL-6), and matching 3-year shelf life. The core distinction—offering multiple kit configurations with varying component combinations—does not alter the fundamental safety and effectiveness profile demonstrated through identical performance testing.
View the full FDA submission: accessdata.fda.gov