510(k) · Cleared
ClearedCultura Collection and Transport System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merit Medical Systems, Inc. · JSM Culture Media, Non-Propagating Transport
Cleared on Mar 3, 2021 as substantially equivalent to K113249 (Puritan Medical Products, LLC, 2012) after a 257-day review. Its family tree reaches back 3 generations to 1991. 2 later devices descend from it.
- Decided
- Mar 3, 2021
- Review
- 257 days
- Class
- Class I
- Product code
- JSM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K910526 (1991). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK910526 Microtest Multi Microbe MediumMicrotest · 1991
- 2 generations backK042970 Copan Universal Transport Medium (Utm-RT) SystemCopan Diagnostics, Inc. · 2004
- 1 generation backK113249 Transport Culture Medium DevicePuritan Medical Products, LLC · 2012
- This deviceK201674 Cultura Collection and Transport SystemMerit Medical Systems, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK242576 AllTest Viral Transport MediumHangzhou AllTest Biotech Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK232357 Copan Universal Transport Medium (UTM-RT) SystemCopan Italia Spa · 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 |
|---|---|---|---|---|---|
| −3 | K910526 | Microtest Multi Microbe Medium | Microtest | 1991 | — |
| −2 | K042970 | Copan Universal Transport Medium (Utm-RT) System | Copan Diagnostics, Inc. | 2004 | — |
| −1 | K113249 | Transport Culture Medium Device | Puritan Medical Products, LLC | 2012 | — |
| 0 (this device) | K201674 | Cultura Collection and Transport System | Merit Medical Systems, Inc. | 2021 | — |
| +1 | K242576 | AllTest Viral Transport Medium | Hangzhou AllTest Biotech Co., Ltd. | 2025 | — |
| +1 | K232357 | Copan Universal Transport Medium (UTM-RT) System | Copan Italia Spa | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K113249 | Transport Culture Medium DeviceSummary page 4…I Product code: JSM, LIO 21 CFR §: 866.2390 Premarket Notification: K113249 Manufacturer: Puritan Medical Products LLC The Merit Cultura™ Col… | 2012 |
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 30 years and passes through 4 companies; a new generation was cleared every 9.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K242576 (Hangzhou AllTest Biotech Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K113249.
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. 2021, 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?
The Merit Cultura™ Collection and Transport System is intended for collection and transport of clinical specimens to the laboratory for standard diagnostic/identification techniques. The Merit Cultura™ Collection and Transport System is a culture-based media that can be used for upper respiratory viral diagnostic assays including Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), and Rhinovirus.
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/K201674 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201674: Cultura Collection and Transport System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201674
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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