510(k) · Cleared
ClearedCopan Liquid Amies Elution Swab (Eswab) Collection and Transport System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Copan Diagnostics, Inc. · JTW System, Transport, Aerobic
Cleared on Jun 23, 2006 as substantially equivalent to K854986 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1986) and 2 other predicates after a 44-day review. Its family tree reaches back 2 generations to 1986. 4 later devices descend from it.
- Decided
- Jun 23, 2006
- Review
- 44 days
- Class
- Class I
- Product code
- JTW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K854986 (1986). 4 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK854986 BBL Port-a-Cul Aerobic Transport Sys, Modified StuBd Becton Dickinson Vacutainer Systems Preanalytic · 1986
- 1 generation backK972448 Copan Venturi Transystem Amies Medium Without CharcoalCopan Italia Spa · 1997
- This deviceK061301 Copan Liquid Amies Elution Swab (Eswab) Collection and Transport…Copan Diagnostics, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK120846 Transport Culture Medium DevicePuritan Medical Products, LLC · 2012
- Descendant · cites it directly · 1 of its ownK121039 Copan Mswab Collection, Transport and Preservation SystemCopan Flock Technologies · 2012
- Descendant · 2 generations on · 0 of its ownK222613 ARX Liquid Amies Collection & Transport SystemArx Sciences, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK211707 BioTeke Sterile Disposable Virus Sampling KitBioteke Corporation (Wuxi) Co., Ltd. · 2022
Most influential descendants
Showing 4 of 4 · See all- K120846Transport Culture Medium DevicePuritan Medical Products, LLC · 2012 · cites it directly1descendant
- K121039Copan Mswab Collection, Transport and Preservation SystemCopan Flock Technologies · 2012 · cites it directly1descendant
- K222613ARX Liquid Amies Collection & Transport SystemArx Sciences, Inc. · 2024 · 2 generations on0descendants
- K211707BioTeke Sterile Disposable Virus Sampling KitBioteke Corporation (Wuxi) Co., Ltd. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K061301 | Copan Liquid Amies Elution Swab (Eswab) Collection and Transport System | Copan Diagnostics, Inc. | 2006 | — |
| +1 | K120846 | Transport Culture Medium Device | Puritan Medical Products, LLC | 2012 | — |
| +1 | K121039 | Copan Mswab Collection, Transport and Preservation System | Copan Flock Technologies | 2012 | — |
| +2 | K222613 | ARX Liquid Amies Collection & Transport System | Arx Sciences, Inc. | 2024 | — |
| +2 | K211707 | BioTeke Sterile Disposable Virus Sampling Kit | Bioteke Corporation (Wuxi) Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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 JTW? 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? (3)
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 |
|---|---|---|---|
| * | K854986 | BBL Port-a-Cul Aerobic Transport Sys, Modified StuSummary page 1…E DEVICES · BBLTm Port-A-CuWM Specimen Collection and Transport Products (Port-A-Cu1T M) Becton, Dickinson and Company K854986 * Copan Venturi Transystem®t Amies Medium Without Charcoal (Venturi Transystem®)… | 1986 |
| * | K972448 | Copan Venturi Transystem Amies Medium Without CharcoalSummary page 1…* Copan Venturi Transystem®t Amies Medium Without Charcoal (Venturi Transystem®) Copan Diagnostics Inc. K972448 and K946287 Copan Diagnostics Inc. 510(k) May 8, 2006 Copan ESwab Collection and Transport System… | 1997 |
| * | K946287 | Copan Venturi Transystem Amies Medium Without CharcoalSummary page 1…Copan Venturi Transystem®t Amies Medium Without Charcoal (Venturi Transystem®) Copan Diagnostics Inc. K972448 and K946287 Copan Diagnostics Inc. 510(k) May 8, 2006 Copan ESwab Collection and Transport System Appendi… | 1995 |
What descends from it? (4)
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 20 years and passes through 3 companies; a new generation was cleared every 11.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K120846 (Puritan Medical Products, LLC, 2012) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K854986.
How does its category compare?
All JTW devicesJTW System, Transport, Aerobic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JTW
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · JTW
Too few JTW 510(k)s in any year since 2007 to give a median.
Recalls per year · JTW
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JTW
36in 2025
MAUDE reports naming product code JTW, 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 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 14 |
| 2018 | 0 | — | 4 | 32 |
| 2019 | 0 | — | 0 | 8 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 0 | — | 0 | 7 |
| 2022 | 0 | — | 1 | 5 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 0 | 37 |
| 2025 | 0 | — | 0 | 36 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Copan Liquid Amies Elution Swab (ESwab) Collection and Transport System is intended for the collection and transport of clinical specimens containing aerobes, anaerobes and fastidious bacteria from the collection site to the testing laboratory. In the laboratory, ESwab specimens are processed using standard clinical laboratory operating procedures for bacterial culture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061301 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061301: Copan Liquid Amies Elution Swab (Eswab) Collection and Transport System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061301
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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