510(k) · Cleared
ClearedCopan Mswab Collection, Transport and Preservation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Copan Flock Technologies · JTW System, Transport, Aerobic
Cleared on May 25, 2012 as substantially equivalent to K061301 (Copan Diagnostics, Inc., 2006) and 1 other predicate after a 50-day review. Its family tree reaches back 3 generations to 1986. 1 later device descends from it.
- Decided
- May 25, 2012
- Review
- 50 days
- Class
- Class I
- Product code
- JTW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K854986 (1986). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK854986 BBL Port-a-Cul Aerobic Transport Sys, Modified StuBd Becton Dickinson Vacutainer Systems Preanalytic · 1986
- 2 generations backK972448 Copan Venturi Transystem Amies Medium Without CharcoalCopan Italia Spa · 1997
- 1 generation backK061301 Copan Liquid Amies Elution Swab (Eswab) Collection and Transport…Copan Diagnostics, Inc. · 2006
- This deviceK121039 Copan Mswab Collection, Transport and Preservation SystemCopan Flock Technologies · 2012
- Descendant · cites it directly · 0 of its ownK211707 BioTeke Sterile Disposable Virus Sampling KitBioteke Corporation (Wuxi) Co., Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K211707BioTeke Sterile Disposable Virus Sampling KitBioteke Corporation (Wuxi) Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K854986 | BBL Port-a-Cul Aerobic Transport Sys, Modified Stu | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986 | — |
| −2 | 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 | — |
| 0 (this device) | K121039 | Copan Mswab Collection, Transport and Preservation System | Copan Flock Technologies | 2012 | — |
| +1 | 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 |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (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 |
|---|---|---|---|
| * | K061301 | Copan Liquid Amies Elution Swab (Eswab) Collection and Transport SystemSummary page 1…Microbiology 3. PREDICATE DEVICES *Copan Liquid Amies Elution Swab (ESwab) Collection and Transport System Copan Diagnostics Inc. K061301 e, Copan Universal Transport Medium (UTM-RT) System Copan Diagnostics Inc. K042970 4. DEVICE DESCRIPTION… | 2006 |
| * | K042970 | Copan Universal Transport Medium (Utm-RT) SystemSummary page 1…lection and Transport System Copan Diagnostics Inc. K061301 e, Copan Universal Transport Medium (UTM-RT) System Copan Diagnostics Inc. K042970 4. DEVICE DESCRIPTION Copan MSwab Collection, Transport and Preservation System is supplied in two different format… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211707 | BioTeke Sterile Disposable Virus Sampling Kit | 2022 | 0 |
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 26 years and passes through 4 companies; a new generation was cleared every 8.8 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K211707 (Bioteke Corporation (Wuxi) Co., Ltd., 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K061301.
How does its category compare?
All JTW devicesJTW System, Transport, Aerobic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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?
MSwab is a Collection, Transport and Preservation System intended for the
collection and transport of clinical specimens containing Gram positive aerobic and
facultative anaerobic bacteria, HSV 1 and HSV 2 from the collection site to the
testing laboratory. In the laboratory, MSwab specimens are processed using
standard clinical laboratory operating procedures for culture.
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/K121039 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121039: Copan Mswab Collection, Transport and Preservation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121039
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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