510(k) · Cleared
Recalled · Class II · 2018Urine Culture Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bd Becton Dickinson Vacutainer Systems Preanalytic · JTW System, Transport, Aerobic
Cleared on Apr 4, 1979 after a 41-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 2 times.
- Decided
- Apr 4, 1979
- Review
- 41 days
- Class
- Class I
- Product code
- JTW
- Recalls
- 2
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JTW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 30, 2018 | Class II | Z-0491-2019 | Under Investigation by firm | BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) counts when used with the Sysmex UF Series Analyzers. BD recommends following Good Clinical Practice (GCP) by using microscopy to confirm an… |
| Oct 12, 2009 | Not classified | Z-1026-2010 | 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.
How does its category compare?
All JTW devicesJTW System, Transport, Aerobic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JTW
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · JTW
Too few JTW 510(k)s in any year since 2007 to give a median.
Recalls per year · JTW
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JTW
36in 2025
MAUDE reports naming product code JTW, 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 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 14 |
| 2018 | 0 | — | 4 | 32 |
| 2019 | 0 | — | 0 | 8 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 0 | — | 0 | 7 |
| 2022 | 0 | — | 1 | 5 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 0 | 37 |
| 2025 | 0 | — | 0 | 36 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K790366 · printed Nov 6, 2026
Cite this page
510(k) Report. “K790366: Urine Culture Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K790366
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026