510(k) · Cleared
ClearedCopan Venturi Transystem Cary-Blair Medium
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, 2 citing it directly.
- This deviceK946286 Copan Venturi Transystem Cary-Blair MediumCopan Diagnostics, Inc. · 1995
- Descendant · cites it directly · 3 of its ownK142094 Copan Fecalswab Collection, Transport and Preservation SystemCopan Italia Spa · 2015
- Descendant · 2 generations on · 0 of its ownK242976 Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and…Medical Wire & Equipment Company (Bath), Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK220052 Copan FecalSwab Collection, Transport and Preservation SystemCopan Italia Spa · 2022
- Descendant · 2 generations on · 0 of its ownK162284 Puritan Fecal Opti-Swab Collection and Transport SystemPuritan Medical Products, LLC · 2016
- Descendant · cites it directly · 0 of its ownK160082 Puritan Opti-Tranz Cary-Blair Collection and Transport SystemPuritan Medical Products, LLC · 2016
Most influential descendants
Showing 5 of 5 · See all- K142094Copan Fecalswab Collection, Transport and Preservation SystemCopan Italia Spa · 2015 · cites it directly3descendants
- K242976Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport DeviceMedical Wire & Equipment Company (Bath), Ltd. · 2025 · 2 generations on0descendants
- K220052Copan FecalSwab Collection, Transport and Preservation SystemCopan Italia Spa · 2022 · 2 generations on0descendants
- K162284Puritan Fecal Opti-Swab Collection and Transport SystemPuritan Medical Products, LLC · 2016 · 2 generations on0descendants
- K160082Puritan Opti-Tranz Cary-Blair Collection and Transport SystemPuritan Medical Products, LLC · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K946286 | Copan Venturi Transystem Cary-Blair Medium | Copan Diagnostics, Inc. | 1995 | — |
| +1 | K142094 | Copan Fecalswab Collection, Transport and Preservation System | Copan Italia Spa | 2015 | — |
| +2 | K242976 | Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport… | Medical Wire & Equipment Company (Bath), Ltd. | 2025 | — |
| +2 | K220052 | Copan FecalSwab Collection, Transport and Preservation System | Copan Italia Spa | 2022 | — |
| +2 | K162284 | Puritan Fecal Opti-Swab Collection and Transport System | Puritan Medical Products, LLC | 2016 | — |
| +1 | K160082 | Puritan Opti-Tranz Cary-Blair Collection and Transport System | Puritan Medical Products, LLC | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2022 | 1 | 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? (5)
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?
- Of its descendants, K142094 (Copan Italia Spa, 2015) has gone furthest, with 3 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/K946286 · printed Nov 6, 2026
Cite this page
510(k) Report. “K946286: Copan Venturi Transystem Cary-Blair Medium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K946286
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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