510(k) · Cleared
ClearedVacu Lab Plain Tube, Vacu Lab Gel & Clot Activator Tube, Vacu Lab Coagulation Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teco Diagnostics · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Jun 15, 2006 as substantially equivalent to K023075 (Bd Vacutainer Systems Preanalyical Solutions, 2002) after a 122-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Jun 15, 2006
- Review
- 122 days
- Class
- Class II
- Product code
- JKA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K960250 (1996). No later device cites it as a predicate yet.
- Root · 2 generations backK960250 Vacutainer Brand Plus Serum & SST TubesBecton Dickinson Vacutainer Systems · 1996 · Recalled
- 1 generation backK023075 BD Vacutainer Plus SST Serum Separator TubeBd Vacutainer Systems Preanalyical Solutions · 2002 · Recalled
- This deviceK060364 Vacu Lab Plain Tube, Vacu Lab Gel & Clot Activator Tube, Vacu Lab…Teco Diagnostics · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K960250 | Vacutainer Brand Plus Serum & SST Tubes | Becton Dickinson Vacutainer Systems | 1996 | 3 |
| −1 | K023075 | BD Vacutainer Plus SST Serum Separator Tube | Bd Vacutainer Systems Preanalyical Solutions | 2002 | 3 |
| 0 (this device) | K060364 | Vacu Lab Plain Tube, Vacu Lab Gel & Clot Activator Tube, Vacu Lab Coagulation… | Teco Diagnostics | 2006 | — |
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 JKA? 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 JKA device
- #1 K200027 Blood Collection Needle with/without Holder…score 15.6 · 3 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 |
|---|---|---|---|
| * | K023075 | BD Vacutainer Plus SST Serum Separator TubeSummary page 2…antially equivalent to the predicate devices. The predicate device is BD Vacutainer TM Plus SST TM Tube The 510 (K) approval letter is provided in Appendix 1. 5 10(K) #: K023075 Approval Date: 11-25-2002 Synopsis of Test Methods and Results Comparison Studies: Clinical evaluations were performed to dete… | 2002 |
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 10 years and passes through 3 companies; a new generation was cleared every 6.7 years on median.
- 2 of the 2 ancestors have a recall of any class.
- 2 other devices also cite its predicate K023075.
How does its category compare?
All JKA devicesJKA Tubes, Vials, Systems, Serum Separators, Blood Collection: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JKA
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JKA
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JKA
13in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JKA
6,089in 2025
MAUDE reports naming product code JKA, 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 | 4 | 281 | 3 | 73 |
| 2008 | 2 | — | 3 | 78 |
| 2009 | 2 | — | 3 | 42 |
| 2010 | 4 | 28 | 4 | 37 |
| 2011 | 0 | — | 14 | 67 |
| 2012 | 1 | — | 2 | 54 |
| 2013 | 3 | 244 | 1 | 33 |
| 2014 | 1 | — | 1 | 68 |
| 2015 | 1 | — | 6 | 41 |
| 2016 | 4 | 116 | 1 | 65 |
| 2017 | 2 | — | 2 | 2,039 |
| 2018 | 1 | — | 2 | 9,731 |
| 2019 | 6 | 181 | 9 | 6,469 |
| 2020 | 6 | 181 | 0 | 3,774 |
| 2021 | 4 | 217 | 3 | 3,610 |
| 2022 | 9 | 164 | 2 | 3,375 |
| 2023 | 17 | 189 | 2 | 4,400 |
| 2024 | 6 | 240 | 0 | 4,609 |
| 2025 | 7 | 115 | 13 | 6,089 |
| 2026 | 8 | 250 | 1 | — |
What is it indicated for?
1. The Vacu Lab Plain Tube is a sterile, plastic, evacuated blood collection tube with a silica clot activator that provides a means of collecting, transporting, separating, and processing blood in a closed tube. The specimens are used for clinical laboratory assays involving the use patient serum.
2. The Vacu Lab Gel & Clot Activator Tube is a sterile, plastic, evacuated of blood collection tube with a silica clot activator and a barrier gel that provides a means of collecting, transporting, separating, and processing blood in a closed tube. The specimens are used for clinical laboratory assays involving the use of patient serum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060364 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060364: Vacu Lab Plain Tube, Vacu Lab Gel & Clot Activator Tube, Vacu Lab Coagulation Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060364
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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