# K946283: Copan Venturi Transystem Liquid Stuarts Medium

- Pathway: 510(k) (Traditional)
- Applicant: Copan Diagnostics, Inc.
- Decided: Mar 10, 1995 after 73 days
- Product code: JSM (Culture Media, Non-Propagating Transport)
- Device class: 1
- Regulation: 21 CFR 866.2390
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K142366: Puritan OptiTranz Liquid Stuart Collection and Transport System (2015), 0 descendants of its own

## Recalls of this device
- Jun 20, 2024 · Class II · Z-2584-2024: Specimen collection device may leak after the patient sample swabs have been inserted into the test tubes, which could result in biohazard exposure, cross contamination causing false positive results 

Source page: https://510kreport.com/device/K946283
Methodology: https://510kreport.com/methodology