510(k) · Cleared
ClearedDisposable Urine Collection Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhejiang Gongdong Medical Technology Co., Ltd. · JSM Culture Media, Non-Propagating Transport
Cleared on Nov 17, 2022 as substantially equivalent to K180052 (Copan Italia Spa, 2018) after a 248-day review. Its family tree reaches back 2 generations to 2003.
- Decided
- Nov 17, 2022
- Review
- 248 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.
- Root · 2 generations backK024240 BD Vacutainer Plus Plastic Urine C&S Preservayive Tubes and KitsBd · 2003 · Recalled
- 1 generation backK180052 UriSwab-Urine Collection, Transport and Preservation SystemCopan Italia Spa · 2018
- This deviceK220739 Disposable Urine Collection TubeZhejiang Gongdong Medical Technology Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K024240 | BD Vacutainer Plus Plastic Urine C&S Preservayive Tubes and Kits | Bd | 2003 | 3 |
| −1 | K180052 | UriSwab-Urine Collection, Transport and Preservation System | Copan Italia Spa | 2018 | — |
| 0 (this device) | K220739 | Disposable Urine Collection Tube | Zhejiang Gongdong Medical Technology Co., Ltd. | 2022 | — |
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 4…ium Regulatory Class: Class I Product Code: JSM, LIO III. PREDICATE DEVICE Primary predicate device: UriSwab™ - Urine Collection, Transport and Preservation System (K180052) Classification Name: Culture Media, Non-Propagating Transport FDA Panel: Microbiology Classification Number: 21 CFR 866.2390, Tr… | 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 19 years and passes through 3 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. 2022, 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?
Disposable Urine Collection Tube is intended for the collection, transport and preservation of urine specimens from the collection site to the testing laboratory. In the laboratory, urine 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/K220739 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220739: Disposable Urine Collection Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220739
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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