# K240235: OmniTrans Transport System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Dakewe Bio-Engineering Co., Ltd.
- Decided: Aug 19, 2024 after 203 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 K910526 (1991). 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)
- K042970: Copan Universal Transport Medium (Utm-RT) System, Copan Diagnostics, Inc. (2004) Summary page 4.

## Indications for use
OmniTrans™ Transport System is intended for use in the collection of clinical specimens (i.e., sputum, throat/oropharyngeal swab, whole blood, urine, skin lesion material or exudate) potentially containing viruses, chlamydiae, mycoplasma, or ureaplasma and in their transport from the collection site to the testing laboratory. The system can be processed using standard clinical laboratory operating procedures for culture of clinical specimens.

Source page: https://510kreport.com/device/K240235
Methodology: https://510kreport.com/methodology