# K212856: iClean Viral Transport System (VTM-RT kit)

- Pathway: 510(k) (Traditional)
- Applicant: Huachenyang (Shenzhen) Technology Co., Ltd.
- Decided: Aug 18, 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 K910526 (1991). 2 ancestors in all.
2 later devices descend from it; 2 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)
- K042970: Copan Universal Transport Medium (Utm-RT) System, Copan Diagnostics, Inc. (2004) Summary page 4.

## Most influential descendants
- K232454: Viral Transport Media (VTM) (2024), 0 descendants of its own
- K231843: ARX Viral Transport Media Collection and Transport System (2024), 0 descendants of its own

## Indications for use
iClean Viral Transport System (VITM-RT) is intended for the collection and transport of clinical specimens containing respiratory viruses, Chlamydiae, or Mycoplasma hominis from the collection site to the testing laboratory. The collection system is a culture based media that is intended to be used with standard laboratory examination, culture or with other assays that utilize stable recoverable infectious viral particles or bacteria.

Source page: https://510kreport.com/device/K212856
Methodology: https://510kreport.com/methodology