510(k) · Cleared
Recalled · 2009BD Vacutainer Plus Plastic Urine C&S Preservayive Tubes and Kits
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bd · JSM Culture Media, Non-Propagating Transport
Cleared on Mar 26, 2003 after a 93-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 5 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 26, 2003
- Review
- 93 days
- Class
- Class I
- Product code
- JSM
- Recalls
- 3
- Predicates
- 1
5 later devices descend from it, 3 citing it directly.
- This deviceK024240 BD Vacutainer Plus Plastic Urine C&S Preservayive Tubes and KitsBd · 2003
- Descendant · cites it directly · 2 of its ownK180052 UriSwab-Urine Collection, Transport and Preservation SystemCopan Italia Spa · 2018
- Descendant · 2 generations on · 0 of its ownK232565 UriSponge™Copan Italia Spa · 2024
- Descendant · 2 generations on · 0 of its ownK220739 Disposable Urine Collection TubeZhejiang Gongdong Medical Technology Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK163436 Greiner Vacuette Urine Count and Culture, Mannitol tubeGreiner Bio-One Na, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK070062 Coproset Salmonella and Shigella, Uriset Preservative Tubes and Swab…Diesse Diagnostica Senese S.P.A. · 2007
Most influential descendants
Showing 5 of 5 · See all- K180052UriSwab-Urine Collection, Transport and Preservation SystemCopan Italia Spa · 2018 · cites it directly2descendants
- K232565UriSponge™Copan Italia Spa · 2024 · 2 generations on0descendants
- K220739Disposable Urine Collection TubeZhejiang Gongdong Medical Technology Co., Ltd. · 2022 · 2 generations on0descendants
- K163436Greiner Vacuette Urine Count and Culture, Mannitol tubeGreiner Bio-One Na, Inc. · 2017 · cites it directly0descendants
- K070062Coproset Salmonella and Shigella, Uriset Preservative Tubes and Swab Set General UseDiesse Diagnostica Senese S.P.A. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K024240 | BD Vacutainer Plus Plastic Urine C&S Preservayive Tubes and Kits | Bd | 2003 | — |
| +1 | K180052 | UriSwab-Urine Collection, Transport and Preservation System | Copan Italia Spa | 2018 | — |
| +2 | K232565 | UriSponge™ | Copan Italia Spa | 2024 | — |
| +2 | K220739 | Disposable Urine Collection Tube | Zhejiang Gongdong Medical Technology Co., Ltd. | 2022 | — |
| +1 | K163436 | Greiner Vacuette Urine Count and Culture, Mannitol tube | Greiner Bio-One Na, Inc. | 2017 | — |
| +1 | K070062 | Coproset Salmonella and Shigella, Uriset Preservative Tubes and Swab Set… | Diesse Diagnostica Senese S.P.A. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K790336 | FDA’s K790336 is Union Carbide Corp. Computer Interface Our reading of the summary gave K790336, FDA’s number for Union Carbide Corp. Computer Interface (Union Carbide Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “BD Vacutainer™ Brand Glass Urine C&S Preservative Tubes and Kits”. Kept off the family tree. Summary page 2…I BD Vacutainer Systems, BD VacutainerTMBrand Glass Urine Preanalyhcal Solutions C&S Preservative Tubes and Kits K790336 414179 Y Jing Zhang… | 1979 |
What descends from it? (5)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 12, 2009 | Not classified | Z-1023-2010 | Other | A small amount of discoloration was noted on Towelettes included in BD Vacutainer Urine collection kits. The entire kit components retain sterile interiors and no viable growth was detected on the towelettes. |
| Oct 12, 2009 | Not classified | Z-1024-2010 | Other | A small amount of discoloration was noted on Towelettes included in BD Vacutainer Urine collection kits. The entire kit components retain sterile interiors and no viable growth was detected on the towelettes. |
| Oct 12, 2009 | Not classified | Z-1025-2010 | Other | A small amount of discoloration was noted on Towelettes included in BD Vacutainer Urine collection kits. The entire kit components retain sterile interiors and no viable growth was detected on the towelettes. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K180052 (Copan Italia Spa, 2018) has gone furthest, with 2 descendants of its own.
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.
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 BD Vacutainer™PLUS Plastic Urine C&S Preservative Tubes and Kits are intended for the collection and transport of urine samples for culture and sensitivity testing of bacteria.
The BD Vacutainer™PLUS Plastic Urine C&S Preservative Tube is filled with lyophilized urine maintenance formula and evacuated to draw approximately 4 - 10 mL (depending on the tube size) of urine. The lyophilized urine maintenance formula can maintain the bacterial population in the urine specimen for a period of 48 hours at room temperature levels comparable to those urine specimens without additive, held under refrigeration for the same period of time.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024240 · printed Nov 3, 2026
Cite this page
510(k) Report. “K024240: BD Vacutainer Plus Plastic Urine C&S Preservayive Tubes and Kits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024240
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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