# K180052: UriSwab-Urine Collection, Transport and Preservation System

- Pathway: 510(k) (Traditional)
- Applicant: Copan Italia Spa
- Decided: Mar 23, 2018 after 74 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: 1 generation back to K024240 (2003). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024240: BD Vacutainer Plus Plastic Urine C&S Preservayive Tubes and Kits, Bd (2003) Summary page 5.

## Most influential descendants
- K232565: UriSponge™ (2024), 0 descendants of its own
- K220739: Disposable Urine Collection Tube (2022), 0 descendants of its own

## Indications for use
Copan UriSwab™ - 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, UriSwab™ specimens are processed using standard clinical laboratory operating procedures for the cultivation of uropathogenic bacteria and yeasts.

Source page: https://510kreport.com/device/K180052
Methodology: https://510kreport.com/methodology