510(k) · Cleared
Recalled · Class II · 2025Copan Easy-Swab 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 Nov 9, 1999 as substantially equivalent to K913789 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1991) after a 48-day review. Its family tree reaches back 1 generation to 1991. It has been recalled once.
- Decided
- Nov 9, 1999
- Review
- 48 days
- Class
- Class I
- Product code
- JTW
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K913789 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK913789 Aerobic Foam Swab Culturette (R)Bd Becton Dickinson Vacutainer Systems Preanalytic · 1991
- This deviceK993161 Copan Easy-Swab Collection and Transport SystemCopan Diagnostics, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913789 | Aerobic Foam Swab Culturette (R) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991 | — |
| 0 (this device) | K993161 | Copan Easy-Swab Collection and Transport System | Copan Diagnostics, Inc. | 1999 | — |
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? (1)
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 |
|---|---|---|---|
| * | K913789 | Aerobic Foam Swab Culturette (R)Summary page 1…n Name: Microbiological Specimen Collection and Transport Device 3. PREDICATE DEVICES Becton Dickinson Culturette EZ and Culturette EZ II Transport Products subject of K913789. | 4. DEVICE DESCRIPTION The Copan Easy-Swab is offered in two configurations. The Copan Easy-Swab I is offered with a single s… | 1991 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 2, 2025 | Class II | Z-1937-2025 | Nonconforming Material/Component | Swabs for specimen collection may be prone to breakage during product usage. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
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?
The Copan Easy-Swab Collection and Transport System products are sterile, single-use specimen collection chambers intended to preserve the viability of aerobic microorganisms after their collection and during their transport from the collecting area to the laboratory. These devices are intended for the collection, transport, and preservation of aerobic clinical specimens for bacteriological examination. The Copan Easy-Swab Collection and Transport System products are designed to support the viability of a wide variety of clinically important aerobic 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/K993161 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993161: Copan Easy-Swab 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/K993161
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