510(k) · Cleared
ClearediClean Viral Transport System (VTM-RT kit)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Huachenyang (Shenzhen) Technology Co., Ltd. · JSM Culture Media, Non-Propagating Transport
Cleared on Aug 18, 2022 as substantially equivalent to K042970 (Copan Diagnostics, Inc., 2004) after a 344-day review. Its family tree reaches back 2 generations to 1991. 2 later devices descend from it.
- Decided
- Aug 18, 2022
- Review
- 344 days
- Class
- Class I
- Product code
- JSM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K910526 (1991). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK910526 Microtest Multi Microbe MediumMicrotest · 1991
- 1 generation backK042970 Copan Universal Transport Medium (Utm-RT) SystemCopan Diagnostics, Inc. · 2004
- This deviceK212856 iClean Viral Transport System (VTM-RT kit)Huachenyang (Shenzhen) Technology Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK232454 Viral Transport Media (VTM)Alb Luz · 2024
- Descendant · cites it directly · 0 of its ownK231843 ARX Viral Transport Media Collection and Transport SystemArx Sciences, Inc. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K910526 | Microtest Multi Microbe Medium | Microtest | 1991 | — |
| −1 | K042970 | Copan Universal Transport Medium (Utm-RT) System | Copan Diagnostics, Inc. | 2004 | — |
| 0 (this device) | K212856 | iClean Viral Transport System (VTM-RT kit) | Huachenyang (Shenzhen) Technology Co., Ltd. | 2022 | — |
| +1 | K232454 | Viral Transport Media (VTM) | Alb Luz | 2024 | — |
| +1 | K231843 | ARX Viral Transport Media Collection and Transport System | Arx Sciences, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JSM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JSM device
- #1 K242976 Medical Wire Fecal Transwab Liquid Cary Blair…score 10.7 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K042970 | Copan Universal Transport Medium (Utm-RT) SystemSummary page 4…e Product Code and JSM; Transport culture medium Panel Code Predicate Device Copan Universal Transport Medium (UTM-RT) System (K042970) 1. Intended Use and Indications for Use iClean Viral Transport System (VTM-RT) is intended for the collection and transport o… | 2004 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 3 companies; a new generation was cleared every 17.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K232454 (Alb Luz, 2024) has gone furthest, with 0 descendants of its own.
- 13 other devices also cite its predicate K042970.
How does its category compare?
All JSM devicesJSM Culture Media, Non-Propagating Transport: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · JSM
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JSM
241in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JSM
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JSM
63in 2025
MAUDE reports naming product code JSM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 3 | 1 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 1 | — | 0 | 9 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 4 | 195 | 0 | 1 |
| 2016 | 2 | — | 0 | 6 |
| 2017 | 1 | — | 0 | 57 |
| 2018 | 1 | — | 0 | 131 |
| 2019 | 0 | — | 0 | 81 |
| 2020 | 0 | — | 4 | 47 |
| 2021 | 1 | — | 1 | 42 |
| 2022 | 5 | 344 | 1 | 36 |
| 2023 | 3 | 254 | 0 | 48 |
| 2024 | 9 | 271 | 0 | 21 |
| 2025 | 3 | 241 | 0 | 63 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K212856 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212856: iClean Viral Transport System (VTM-RT kit).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212856
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026