# K220739: Disposable Urine Collection Tube

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Gongdong Medical Technology Co., Ltd.
- Decided: Nov 17, 2022 after 248 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 4.

## Indications for use
Disposable Urine Collection Tube is intended for the collection, transport and preservation of urine specimens from the collection site to the testing laboratory. In the laboratory, urine specimens are processed using standard clinical laboratory operating procedures for the cultivation of uropathogenic bacteria and yeasts.

Source page: https://510kreport.com/device/K220739
Methodology: https://510kreport.com/methodology