510(k) · Cleared
ClearedGreiner Vacuette Urine Count and Culture, Mannitol tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Greiner Bio-One Na, Inc. · JSM Culture Media, Non-Propagating Transport
Cleared on Mar 6, 2017 as substantially equivalent to K024240 (Bd, 2003) after an 89-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Mar 6, 2017
- Review
- 89 days
- Class
- Class I
- Product code
- JSM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K024240 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backK024240 BD Vacutainer Plus Plastic Urine C&S Preservayive Tubes and KitsBd · 2003 · Recalled
- This deviceK163436 Greiner Vacuette Urine Count and Culture, Mannitol tubeGreiner Bio-One Na, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K024240 | BD Vacutainer Plus Plastic Urine C&S Preservayive Tubes and Kits | Bd | 2003 | 3 |
| 0 (this device) | K163436 | Greiner Vacuette Urine Count and Culture, Mannitol tube | Greiner Bio-One Na, Inc. | 2017 | — |
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 |
|---|---|---|---|
| * | K024240 | BD Vacutainer Plus Plastic Urine C&S Preservayive Tubes and KitsSummary page 4…icrobiology 3. PREDICATE DEVICE - CLASSIFICATION Device name: BD Vacutainer Plus Plastic Urine C&S Tube 510(k) number: K024240 Device: Culture Media, Non-Propagating Transport Regulatory Description: Transport cu… | 2003 |
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?
- Its one ancestor has a recall.
- 2 other devices also cite its predicate K024240.
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. 2017, 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?
The Greiner Vacuette Urine Count and Culture, Mannitol tube is a urine stabilization device intended for collection, transport and storage of urine for bacterial and yeast culture. Urine samples collected in the Greiner Vacuette Urine Count and Culture, Mannitol tube can be stored at 20-25°C for up to 48 h prior to culture. This device is intended for professional use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163436 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163436: Greiner Vacuette Urine Count and Culture, Mannitol tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163436
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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