510(k) · Cleared
ClearedCopan Venturi Transystem Amies Medium Without Charcoal
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 Mar 10, 1995 after a 73-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Mar 10, 1995
- Review
- 73 days
- Class
- Class I
- Product code
- JSM
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK946287 Copan Venturi Transystem Amies Medium Without CharcoalCopan Diagnostics, Inc. · 1995
- Descendant · cites it directly · 4 of its ownK061301 Copan Liquid Amies Elution Swab (Eswab) Collection and Transport…Copan Diagnostics, Inc. · 2006
- Descendant · 2 generations on · 1 of its ownK120846 Transport Culture Medium DevicePuritan Medical Products, LLC · 2012
- Descendant · 2 generations on · 1 of its ownK121039 Copan Mswab Collection, Transport and Preservation SystemCopan Flock Technologies · 2012
- Descendant · 3 generations on · 0 of its ownK222613 ARX Liquid Amies Collection & Transport SystemArx Sciences, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK211707 BioTeke Sterile Disposable Virus Sampling KitBioteke Corporation (Wuxi) Co., Ltd. · 2022
Most influential descendants
Showing 5 of 5 · See all- K061301Copan Liquid Amies Elution Swab (Eswab) Collection and Transport SystemCopan Diagnostics, Inc. · 2006 · cites it directly4descendants
- K120846Transport Culture Medium DevicePuritan Medical Products, LLC · 2012 · 2 generations on1descendant
- K121039Copan Mswab Collection, Transport and Preservation SystemCopan Flock Technologies · 2012 · 2 generations on1descendant
- K222613ARX Liquid Amies Collection & Transport SystemArx Sciences, Inc. · 2024 · 3 generations on0descendants
- K211707BioTeke Sterile Disposable Virus Sampling KitBioteke Corporation (Wuxi) Co., Ltd. · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K946287 | Copan Venturi Transystem Amies Medium Without Charcoal | Copan Diagnostics, Inc. | 1995 | — |
| +1 | K061301 | Copan Liquid Amies Elution Swab (Eswab) Collection and Transport System | Copan Diagnostics, Inc. | 2006 | — |
| +2 | K120846 | Transport Culture Medium Device | Puritan Medical Products, LLC | 2012 | — |
| +2 | K121039 | Copan Mswab Collection, Transport and Preservation System | Copan Flock Technologies | 2012 | — |
| +3 | K222613 | ARX Liquid Amies Collection & Transport System | Arx Sciences, Inc. | 2024 | — |
| +3 | 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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2012 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061301 | Copan Liquid Amies Elution Swab (Eswab) Collection and Transport System | 2006 | 4 |
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, K061301 (Copan Diagnostics, Inc., 2006) has gone furthest, with 4 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/K946287 · printed Nov 4, 2026
Cite this page
510(k) Report. “K946287: Copan Venturi Transystem Amies Medium Without Charcoal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K946287
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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