510(k) · Cleared
ClearedUriSponge™
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 Oct 11, 2024 as substantially equivalent to K180052 (Copan Italia Spa, 2018) after a 414-day review. Its family tree reaches back 2 generations to 2003.
- Decided
- Oct 11, 2024
- Review
- 414 days
- Class
- Class I
- Product code
- JSM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K024240 (2003). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K180052 | UriSwab-Urine Collection, Transport and Preservation SystemSummary page 5…ame Transport Culture Medium Regulatory Class Class I Product code JSM, LIO Premarket Notification K180052 Manufacturer Copan Italia S.p.A. CONFIDENTIAL AND PROPRIETARY… | 2018 |
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 2 companies; a new generation was cleared every 15.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K180052.
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. 2024, 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?
Copan UriSponge™ - Urine Collection, Transport, and Preservation System is intended for the collection, transport and
preservation of urine specimens from the collection site to the testing laboratory. In the laboratory, UriSponge™
specimens are processed using standard clinical laboratory operating procedures for the cultivation of uropathogenic
bacteria and yeasts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232565 · printed Nov 5, 2026
Cite this page
510(k) Report. “K232565: UriSponge™.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K232565
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