510(k) · Cleared
ClearedCopan Universal Transport Medium (Utm-RT) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Copan Diagnostics, Inc. · JSM Culture Media, Non-Propagating Transport
Cleared on Dec 7, 2004 as substantially equivalent to K910526 (Microtest, 1991) after a 40-day review. Its family tree reaches back 1 generation to 1991. 24 later devices descend from it.
- Decided
- Dec 7, 2004
- Review
- 40 days
- Class
- Class I
- Product code
- JSM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K910526 (1991). 24 later devices descend from it, 14 citing it directly.
- Root · 1 generation backK910526 Microtest Multi Microbe MediumMicrotest · 1991
- This deviceK042970 Copan Universal Transport Medium (Utm-RT) SystemCopan Diagnostics, Inc. · 2004
- Descendant · cites it directly · 5 of its ownK142045 Xpert Flu/RSV XC AssayCepheid · 2014
- Descendant · cites it directly · 4 of its ownK151226 Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit…Cepheid · 2015
- Descendant · cites it directly · 4 of its ownK113249 Transport Culture Medium DevicePuritan Medical Products, LLC · 2012
- Descendant · cites it directly · 2 of its ownK212856 iClean Viral Transport System (VTM-RT kit)Huachenyang (Shenzhen) Technology Co., Ltd. · 2022
- Descendant · 2 generations on · 2 of its ownK201674 Cultura Collection and Transport SystemMerit Medical Systems, Inc. · 2021
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K142045Xpert Flu/RSV XC AssayCepheid · 2014 · cites it directly5descendants
- K151226Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress…Cepheid · 2015 · cites it directly4descendants
- K113249Transport Culture Medium DevicePuritan Medical Products, LLC · 2012 · cites it directly4descendants
- K212856iClean Viral Transport System (VTM-RT kit)Huachenyang (Shenzhen) Technology Co., Ltd. · 2022 · cites it directly2descendants
- K201674Cultura Collection and Transport SystemMerit Medical Systems, Inc. · 2021 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910526 | Microtest Multi Microbe Medium | Microtest | 1991 | — |
| 0 (this device) | K042970 | Copan Universal Transport Medium (Utm-RT) System | Copan Diagnostics, Inc. | 2004 | — |
| +1 | K142045 | Xpert Flu/RSV XC Assay | Cepheid | 2014 | — |
| +1 | K151226 | Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert… | Cepheid | 2015 | — |
| +1 | K113249 | Transport Culture Medium Device | Puritan Medical Products, LLC | 2012 | — |
| +1 | K212856 | iClean Viral Transport System (VTM-RT kit) | Huachenyang (Shenzhen) Technology Co., Ltd. | 2022 | — |
| +2 | K201674 | Cultura Collection and Transport System | Merit Medical Systems, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 |
|---|---|---|---|
| * | K910526 | Microtest Multi Microbe MediumSummary page 1…ransport Culture Medium Devices 3. PREDICATE DEVICES * Multi-Microbe Collection & Transport System, M4 Medium MicroTest Inc. K910526 • MicroTestTM Multi-Microbe Collection & Transport System, M4 Medium REMEL - Apogent [Covere… | 1991 |
What descends from it? (24)
See all 2414 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142045 | Xpert Flu/RSV XC Assay | 2014 | 5 |
| K151226 | Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress… | 2015 | 4 |
| K113249 | Transport Culture Medium Device | 2012 | 4 |
| K212856 | iClean Viral Transport System (VTM-RT kit) | 2022 | 2 |
| K212743 | MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System | 2023 | 1 |
| K171552 | Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample… | 2017 | 1 |
| K121039 | Copan Mswab Collection, Transport and Preservation System | 2012 | 1 |
| K220908 | Ensol EnTM Specimen Collection and Transport System | 2024 | 0 |
| K240235 | OmniTrans Transport System | 2024 | 0 |
| K233534 | Viral Transport Medium | 2024 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K142045 (Cepheid, 2014) has gone furthest, with 5 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 | — |
What is it indicated for?
Copan Universal Transport Medium (UTM-RT) System is intended for the collection and transport of clinical specimens containing viruses, chlamydiae, mycoplasma or ureaplasma from the collection site to the testing laboratory. UTM-RT can be processed using standard clinical laboratory operating procedures for viral, chlamydial, mycoplasma and ureaplasma culture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042970 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042970: Copan Universal Transport Medium (Utm-RT) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042970
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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