510(k) · Cleared
ClearedCopan Venturi Transystem Amies Medium with Charcoal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Copan Italia Spa · JSL Culture Media, Anaerobic Transport
Cleared on Aug 20, 1997 as substantially equivalent to K960997 (Starplex Scientific, Inc., 1996) and 1 other predicate after a 51-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Aug 20, 1997
- Review
- 51 days
- Class
- Class I
- Product code
- JSL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K854986 (1986). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK854986 BBL Port-a-Cul Aerobic Transport Sys, Modified StuBd Becton Dickinson Vacutainer Systems Preanalytic · 1986
- This deviceK972449 Copan Venturi Transystem Amies Medium with CharcoalCopan Italia Spa · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K854986 | BBL Port-a-Cul Aerobic Transport Sys, Modified Stu | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986 | — |
| 0 (this device) | K972449 | Copan Venturi Transystem Amies Medium with Charcoal | Copan Italia Spa | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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 JSL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K960997 | Starswab Culture Collection and Transport SystemSummary page 2…l Specimen Collection and Transport Device Classification Status: Class I 3. Predicate Devices « Starswab Culture Collection and Transport System Starplex Scientific K960997 e Port-A-Cul Specimen Collection and Transport Products Becton Dickinson K854986 Copan Diagnostics Inc. Amies Medium With Charc… | 1996 |
| * | K854986 | BBL Port-a-Cul Aerobic Transport Sys, Modified StuSummary page 2…dicate Devices « Starswab Culture Collection and Transport System Starplex Scientific K960997 e Port-A-Cul Specimen Collection and Transport Products Becton Dickinson K854986 Copan Diagnostics Inc. Amies Medium With Charcoal 510(k) 6/27/97 Page F-1 4. Device Description The Copan Ventur… | 1986 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K960997.
How does its category compare?
All JSL devicesJSL Culture Media, Anaerobic Transport: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JSL
FDA has decided no JSL device since 2007.
Median 510(k) review, days · JSL
Too few JSL 510(k)s in any year since 2007 to give a median.
Recalls per year · JSL
No recall names JSL since 2007.
Adverse event reports per year · JSL
1in 2023
MAUDE reports naming product code JSL, 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 | 1 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 5 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 7 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Copan Venturi Transystem Amies Medium With Charcoal products are sterile, single-use specimen collection chambers intended to preserve the viability of microorganisms after their collection and (luring their transport from the coHecting area to the laboratory. These devices are intended for the collection, transport, and preservation of clinical specimens for l)acteriological examination. Copan Venturi Transystem Amies Medium With Charcoal is Aesigned to support the viability of a wide variety of clim’cafly important aerobic and anaerobic bacteria.
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/K972449 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972449: Copan Venturi Transystem Amies Medium with Charcoal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972449
Report an extraction error
Are you the manufacturer?
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