510(k) · Cleared
ClearedPuritan Fecal Opti-Swab Collection and Transport System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Puritan Medical Products, LLC · JSM Culture Media, Non-Propagating Transport
Cleared on Nov 4, 2016 as substantially equivalent to K142094 (Copan Italia Spa, 2015) after an 81-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Nov 4, 2016
- Review
- 81 days
- Class
- Class I
- Product code
- JSM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K946286 (1995). No later device cites it as a predicate yet.
- Root · 2 generations backK946286 Copan Venturi Transystem Cary-Blair MediumCopan Diagnostics, Inc. · 1995
- 1 generation backK142094 Copan Fecalswab Collection, Transport and Preservation SystemCopan Italia Spa · 2015
- This deviceK162284 Puritan Fecal Opti-Swab Collection and Transport SystemPuritan Medical Products, LLC · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K946286 | Copan Venturi Transystem Cary-Blair Medium | Copan Diagnostics, Inc. | 1995 | — |
| −1 | K142094 | Copan Fecalswab Collection, Transport and Preservation System | Copan Italia Spa | 2015 | — |
| 0 (this device) | K162284 | Puritan Fecal Opti-Swab Collection and Transport System | Puritan Medical Products, LLC | 2016 | — |
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 |
|---|---|---|---|
| * | K142094 | Copan Fecalswab Collection, Transport and Preservation SystemSummary page 4…) 5.4 Predicate Device Copan Fecal Swab Collection, Transport and Preservation System manufactured by Copan Diagnostics Inc. of Italy 510K Number: K142094 1 5.5 Device… | 2015 |
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?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 20.1 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K142094.
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. 2016, 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?
Puritan Fecal Opti-Swab Collection and Transport System is intended for use in the collection and transport of clinical fecal and rectal swab specimens to preserve the viability of enteric bacteria during transport from the collection site to the testing laboratory for bacteriological examination and culture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162284 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162284: Puritan Fecal Opti-Swab Collection and Transport System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162284
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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