510(k) · Cleared
ClearedAllTest Viral Transport Medium
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hangzhou AllTest Biotech Co., Ltd. · JSM Culture Media, Non-Propagating Transport
Cleared on Apr 4, 2025 as substantially equivalent to K201674 (Merit Medical Systems, Inc., 2021) after a 218-day review. Its family tree reaches back 4 generations to 1991.
- Decided
- Apr 4, 2025
- Review
- 218 days
- Class
- Class I
- Product code
- JSM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K910526 (1991). No later device cites it as a predicate yet.
- Root · 4 generations backK910526 Microtest Multi Microbe MediumMicrotest · 1991
- 3 generations backK042970 Copan Universal Transport Medium (Utm-RT) SystemCopan Diagnostics, Inc. · 2004
- 2 generations backK113249 Transport Culture Medium DevicePuritan Medical Products, LLC · 2012
- 1 generation backK201674 Cultura Collection and Transport SystemMerit Medical Systems, Inc. · 2021
- This deviceK242576 AllTest Viral Transport MediumHangzhou AllTest Biotech Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K910526 | Microtest Multi Microbe Medium | Microtest | 1991 | — |
| −3 | K042970 | Copan Universal Transport Medium (Utm-RT) System | Copan Diagnostics, Inc. | 2004 | — |
| −2 | K113249 | Transport Culture Medium Device | Puritan Medical Products, LLC | 2012 | — |
| −1 | K201674 | Cultura Collection and Transport System | Merit Medical Systems, Inc. | 2021 | — |
| 0 (this device) | K242576 | AllTest Viral Transport Medium | Hangzhou AllTest Biotech Co., Ltd. | 2025 | — |
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 |
|---|---|---|---|
| * | K201674 | Cultura Collection and Transport SystemSummary page 5…Microbiology Transport Culture Medium 5. Predicate Devices: Merit Cultura™ Collection and Transport System (K201674) 6. Indications for Use AllTest Viral Transport Medium (VTM) is intended for collection and transport of clinical specimen… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 34 years and passes through 5 companies; a new generation was cleared every 9.0 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K201674.
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. 2025, 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?
AllTest Viral Transport Medium (VTM) is intended for collection and transport of clinical specimens containing viral agents including Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), and Rhinovirus from collection site to the testing laboratory. Specimens collected in the AllTest VTM can be processed using standard clinical laboratory operating procedure for viral culture.
The AllTest Viral Transport Medium is also intended for the stabilization and transportation of an unprocessed upper respiratory clinical specimen suspected of containing SARS-CoV-2 nucleic acid. The AllTest VTM is suitable for use with compatible legally marketed molecular diagnostic devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242576 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242576: AllTest Viral Transport Medium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242576
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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