# K071496: Icath, Sterilesure

- Pathway: 510(k) (Traditional)
- Applicant: Colorado Catheter Company, Inc.
- Decided: Aug 15, 2007 after 76 days
- Product code: NWO (Kit, Catheter, Urinary (Exludes Hiv Testing))
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K003874 (2001). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052440: Mentor Self-Cath Hydrogel Intermittent Catheter, Mentor Corporation (2005) Summary page 2.

## Most influential descendants
- K103043: Colorado Catheter Sterilesure - New Name Perfic Cath (2011), 1 descendant of its own
- K161445: PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C (2016), 0 descendants of its own

## Indications for use
The Colorado Catheter iCathTM and SterileSure TM are intended for use in adult male and adult female patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals who are unable to promote natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode.

Source page: https://510kreport.com/device/K071496
Methodology: https://510kreport.com/methodology