510(k) · Cleared
ClearedTransport Culture Medium Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Puritan Medical Products, LLC · JSM Culture Media, Non-Propagating Transport
Cleared on Mar 1, 2012 as substantially equivalent to K042970 (Copan Diagnostics, Inc., 2004) after a 119-day review. Its family tree reaches back 2 generations to 1991. 4 later devices descend from it.
- Decided
- Mar 1, 2012
- Review
- 119 days
- Class
- Class I
- Product code
- JSM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K910526 (1991). 4 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 deviceK113249 Transport Culture Medium DevicePuritan Medical Products, LLC · 2012
- Descendant · cites it directly · 2 of its ownK201674 Cultura Collection and Transport SystemMerit Medical Systems, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK242576 AllTest Viral Transport MediumHangzhou AllTest Biotech Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK232357 Copan Universal Transport Medium (UTM-RT) SystemCopan Italia Spa · 2024
- Descendant · cites it directly · 0 of its ownK211707 BioTeke Sterile Disposable Virus Sampling KitBioteke Corporation (Wuxi) Co., Ltd. · 2022
Most influential descendants
Showing 4 of 4 · See all- K201674Cultura Collection and Transport SystemMerit Medical Systems, Inc. · 2021 · cites it directly2descendants
- K242576AllTest Viral Transport MediumHangzhou AllTest Biotech Co., Ltd. · 2025 · 2 generations on0descendants
- K232357Copan Universal Transport Medium (UTM-RT) SystemCopan Italia Spa · 2024 · 2 generations on0descendants
- K211707BioTeke Sterile Disposable Virus Sampling KitBioteke Corporation (Wuxi) Co., Ltd. · 2022 · cites it directly0descendants
View 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) | K113249 | Transport Culture Medium Device | Puritan Medical Products, LLC | 2012 | — |
| +1 | K201674 | Cultura Collection and Transport System | Merit Medical Systems, Inc. | 2021 | — |
| +2 | K242576 | AllTest Viral Transport Medium | Hangzhou AllTest Biotech Co., Ltd. | 2025 | — |
| +2 | K232357 | Copan Universal Transport Medium (UTM-RT) System | Copan Italia Spa | 2024 | — |
| +1 | K211707 | BioTeke Sterile Disposable Virus Sampling Kit | Bioteke Corporation (Wuxi) Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 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 |
|---|---|---|---|
| * | K042970 | Copan Universal Transport Medium (Utm-RT) SystemSummary page 2…mal and ureaplasmal culture. 3.7. Substantial Equivalence Determination A.Predicate Device. * Copan (BD) UTM-RT B. Predicate Devise 510(k) Number(s) K04 2970 C.Comparison of the test device with Predicate device The Puritan UTM-RT Transport Systems are similar in design… | 2004 |
What descends from it? (4)
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 21 years and passes through 3 companies; a new generation was cleared every 13.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K201674 (Merit Medical Systems, Inc., 2021) has gone furthest, with 2 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. 2012, 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?
Puritan UTM -. RT Collection and Transport System is intended for the collection and transport of clinical samples containing viruses, chlamydiae, mycoplasmas and
ureaplasmas from the collection site to the testing laboratory. The specimen
transported in the Puritan UTM - RT can be used in the laboratory to perform viral,
chiamydial, mycoplasmal and ureaplasmal culture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113249 · printed Nov 3, 2026
Cite this page
510(k) Report. “K113249: Transport Culture Medium Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K113249
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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