510(k) · Cleared
ClearedBBL Port-a-Cul Aerobic Transport Sys, Modified Stu
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bd Becton Dickinson Vacutainer Systems Preanalytic · JSM Culture Media, Non-Propagating Transport
Cleared on Jan 3, 1986 after a 22-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Jan 3, 1986
- Review
- 22 days
- Class
- Class I
- Product code
- JSM
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 3 citing it directly.
- This deviceK854986 BBL Port-a-Cul Aerobic Transport Sys, Modified StuBd Becton Dickinson Vacutainer Systems Preanalytic · 1986
- Descendant · cites it directly · 6 of its ownK972448 Copan Venturi Transystem Amies Medium Without CharcoalCopan Italia Spa · 1997
- 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
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K972448Copan Venturi Transystem Amies Medium Without CharcoalCopan Italia Spa · 1997 · cites it directly6descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K854986 | BBL Port-a-Cul Aerobic Transport Sys, Modified Stu | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986 | — |
| +1 | K972448 | Copan Venturi Transystem Amies Medium Without Charcoal | Copan Italia Spa | 1997 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 2006 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 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? (8)
3 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, K972448 (Copan Italia Spa, 1997) has gone furthest, with 6 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/K854986 · printed Nov 4, 2026
Cite this page
510(k) Report. “K854986: BBL Port-a-Cul Aerobic Transport Sys, Modified Stu.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K854986
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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