# K242049: SureCath Set

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast Corp.
- Decided: Nov 26, 2024 after 137 days
- Product code: EZD (Catheter, Straight)
- 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 K910022 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973070: Conveen Easicath Set, Coloplast Corp. (1997). Our reading of the summary gave K973090, FDA’s number for Medstation (Program S.R.L.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Conveen EasiCath Set”. Summary page 6.

## Indications for use
The product is intended for use in male, female, and pediatric patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals unable to promote a 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/K242049
Methodology: https://510kreport.com/methodology