# K142094: Copan Fecalswab Collection, Transport and Preservation System

- Pathway: 510(k) (Traditional)
- Applicant: Copan Italia Spa
- Decided: Apr 10, 2015 after 252 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 K946286 (1995). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K946286: Copan Venturi Transystem Cary-Blair Medium, Copan Diagnostics, Inc. (1995) Summary page 4.

## Most influential descendants
- K242976: Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device (2025), 0 descendants of its own
- K220052: Copan FecalSwab Collection, Transport and Preservation System (2022), 0 descendants of its own
- K162284: Puritan Fecal Opti-Swab Collection and Transport System (2016), 0 descendants of its own

## Indications for use
The Copan FecalSwab Collection, Transport and Preservation System is intended for the collection of rectal swab and fecal specimens and to preserve the viability of enteric pathogenic bacteria 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.

Source page: https://510kreport.com/device/K142094
Methodology: https://510kreport.com/methodology