# K232565: UriSponge™

- Pathway: 510(k) (Traditional)
- Applicant: Copan Italia Spa
- Decided: Oct 11, 2024 after 414 days
- Product code: JSM (Culture Media, Non-Propagating Transport)
- Device class: 1
- Regulation: 21 CFR 866.2390
- 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 K024240 (2003). 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)
- K180052: UriSwab-Urine Collection, Transport and Preservation System, Copan Italia Spa (2018) Summary page 5.

## Indications for use
Copan UriSponge™ - Urine Collection, Transport, and Preservation System is intended for the collection, transport and preservation of urine specimens from the collection site to the testing laboratory. In the laboratory, UriSponge™ specimens are processed using standard clinical laboratory operating procedures for the cultivation of uropathogenic bacteria and yeasts.

Source page: https://510kreport.com/device/K232565
Methodology: https://510kreport.com/methodology