510(k) · Cleared
ClearedMicrotest Multi Microbe Medium
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microtest · JSM Culture Media, Non-Propagating Transport
Cleared on Apr 9, 1991 after a 61-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 25 later devices descend from it.
- Decided
- Apr 9, 1991
- Review
- 61 days
- Class
- Class I
- Product code
- JSM
- Recalls
- None
- Predicates
- 0
25 later devices descend from it, 1 citing it directly.
- This deviceK910526 Microtest Multi Microbe MediumMicrotest · 1991
- Descendant · cites it directly · 24 of its ownK042970 Copan Universal Transport Medium (Utm-RT) SystemCopan Diagnostics, Inc. · 2004
- Descendant · 2 generations on · 5 of its ownK142045 Xpert Flu/RSV XC AssayCepheid · 2014
- Descendant · 2 generations on · 4 of its ownK151226 Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit…Cepheid · 2015
- Descendant · 2 generations on · 4 of its ownK113249 Transport Culture Medium DevicePuritan Medical Products, LLC · 2012
- Descendant · 2 generations on · 2 of its ownK212856 iClean Viral Transport System (VTM-RT kit)Huachenyang (Shenzhen) Technology Co., Ltd. · 2022
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K042970Copan Universal Transport Medium (Utm-RT) SystemCopan Diagnostics, Inc. · 2004 · cites it directly24descendants
- K142045Xpert Flu/RSV XC AssayCepheid · 2014 · 2 generations on5descendants
- K151226Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress…Cepheid · 2015 · 2 generations on4descendants
- K113249Transport Culture Medium DevicePuritan Medical Products, LLC · 2012 · 2 generations on4descendants
- K212856iClean Viral Transport System (VTM-RT kit)Huachenyang (Shenzhen) Technology Co., Ltd. · 2022 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K910526 | Microtest Multi Microbe Medium | Microtest | 1991 | — |
| +1 | K042970 | Copan Universal Transport Medium (Utm-RT) System | Copan Diagnostics, Inc. | 2004 | — |
| +2 | K142045 | Xpert Flu/RSV XC Assay | Cepheid | 2014 | — |
| +2 | K151226 | Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert… | Cepheid | 2015 | — |
| +2 | K113249 | Transport Culture Medium Device | Puritan Medical Products, LLC | 2012 | — |
| +2 | K212856 | iClean Viral Transport System (VTM-RT kit) | Huachenyang (Shenzhen) Technology Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 8 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (25)
See all 251 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042970 | Copan Universal Transport Medium (Utm-RT) System | 2004 | 24 |
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?
- Of its descendants, K042970 (Copan Diagnostics, Inc., 2004) has gone furthest, with 24 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K910526 · printed Nov 4, 2026
Cite this page
510(k) Report. “K910526: Microtest Multi Microbe Medium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K910526
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026