# K220052: Copan FecalSwab Collection, Transport and Preservation System

- Pathway: 510(k) (Traditional)
- Applicant: Copan Italia Spa
- Decided: Dec 16, 2022 after 344 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 K946286 (1995). 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)
- K142094: Copan Fecalswab Collection, Transport and Preservation System, Copan Italia Spa (2015) Summary page 5.

## Indications for use
The Copan FecalSwab Collection, Transport and Preservation System is intended for collection and preservation of viable enteric pathogenic bacteria from rectal swabs and stool specimens during transport from the collection site to the testing laboratory. In the laboratory, FecalSwab specimens are processed using standard clinical laboratory operating procedures for culture. Stool specimens collected with the Copan FecalSwab are also suitable for use with the BD MAX Enteric Bacterial Panel and the BD MAX Extended Enteric Bacterial Panel.

Source page: https://510kreport.com/device/K220052
Methodology: https://510kreport.com/methodology