510(k) · Cleared
ClearedCopan Fecalswab Collection, Transport and Preservation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Copan Italia Spa · JSM Culture Media, Non-Propagating Transport
Cleared on Apr 10, 2015 as substantially equivalent to K946286 (Copan Diagnostics, Inc., 1995) after a 252-day review. Its family tree reaches back 1 generation to 1995. 3 later devices descend from it.
- Decided
- Apr 10, 2015
- Review
- 252 days
- Class
- Class I
- Product code
- JSM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K946286 (1995). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK946286 Copan Venturi Transystem Cary-Blair MediumCopan Diagnostics, Inc. · 1995
- This deviceK142094 Copan Fecalswab Collection, Transport and Preservation SystemCopan Italia Spa · 2015
- Descendant · cites it directly · 0 of its ownK242976 Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and…Medical Wire & Equipment Company (Bath), Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK220052 Copan FecalSwab Collection, Transport and Preservation SystemCopan Italia Spa · 2022
- Descendant · cites it directly · 0 of its ownK162284 Puritan Fecal Opti-Swab Collection and Transport SystemPuritan Medical Products, LLC · 2016
Most influential descendants
Showing 3 of 3 · See all- K242976Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport DeviceMedical Wire & Equipment Company (Bath), Ltd. · 2025 · cites it directly0descendants
- K220052Copan FecalSwab Collection, Transport and Preservation SystemCopan Italia Spa · 2022 · cites it directly0descendants
- K162284Puritan Fecal Opti-Swab Collection and Transport SystemPuritan Medical Products, LLC · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K946286 | Copan Venturi Transystem Cary-Blair Medium | Copan Diagnostics, Inc. | 1995 | — |
| 0 (this device) | K142094 | Copan Fecalswab Collection, Transport and Preservation System | Copan Italia Spa | 2015 | — |
| +1 | K242976 | Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport… | Medical Wire & Equipment Company (Bath), Ltd. | 2025 | — |
| +1 | K220052 | Copan FecalSwab Collection, Transport and Preservation System | Copan Italia Spa | 2022 | — |
| +1 | K162284 | Puritan Fecal Opti-Swab Collection and Transport System | Puritan Medical Products, LLC | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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 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? (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 |
|---|---|---|---|
| * | K946286 | Copan Venturi Transystem Cary-Blair MediumSummary page 4…on Regulation: 866.2390 Product Code: JSM, LIO Class: 1 3. PREDICATE DEVICE • Copan Venturi Transystem Cary-Blair Medium - K946286 4. DEVICE DESCRIPTION The Copan FecalSwab Collection, Transport and Preservation System (Copan FecalSwab System) is supp… | 1995 |
What descends from it? (3)
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?
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. 2015, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Copan FecalSwab Collection, Transport and Preservation System is intended for the collection of rectal swab and fecal specimens and to preserve the viability of enteric pathogenic bacteria during transport from the collection site to the testing laboratory. In the laboratory, FecalSwab specimens are processed using standard clinical laboratory operating procedures for culture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142094 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142094: Copan Fecalswab 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/K142094
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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