510(k) · Cleared
ClearedVacuette Evacuated Blood Collection Tubes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Greiner Bio-One Vacuette North America · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Jun 28, 2001 as substantially equivalent to K960857 (Greiner America, Inc., 1996) after a 27-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Jun 28, 2001
- Review
- 27 days
- Class
- Class II
- Product code
- JKA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K944566 (1994). No later device cites it as a predicate yet.
- Root · 2 generations backK944566 Vacutainer Brand Plus Sodium Heparin TubeBd Becton Dickinson Vacutainer Systems Preanalytic · 1994 · Recalled
- 1 generation backK960857 Greiner Vacuette Blood Collection Tube W/Lithium Heparin & Gel…Greiner America, Inc. · 1996 · Recalled
- This deviceK011699 Vacuette Evacuated Blood Collection TubesGreiner Bio-One Vacuette North America · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K944566 | Vacutainer Brand Plus Sodium Heparin Tube | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1994 | 2 |
| −1 | K960857 | Greiner Vacuette Blood Collection Tube W/Lithium Heparin & Gel Separator | Greiner America, Inc. | 1996 | 5 |
| 0 (this device) | K011699 | Vacuette Evacuated Blood Collection Tubes | Greiner Bio-One Vacuette North America | 2001 | — |
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 |
|---|---|---|---|
| * | K960857 | Greiner Vacuette Blood Collection Tube W/Lithium Heparin & Gel SeparatorSummary page 1…tantial Equivalence: The Greiner VACUETTE® tube with sodium heparin has been found to be substantially equivalent to the Greiner VACUETTE® tube with lithium heparin (K# 960857). Both blood collection tubes have the same intended use and contain the same tube material and stopper material. The tubes have… | 1996 |
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 7 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- 2 of the 2 ancestors have a recall of any class.
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?
VACUETTE® tubes with sodium heparin are used to collect, transport and process
blood for testing plasma or whole blood in the clinical laboratory.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011699 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011699: Vacuette Evacuated Blood Collection Tubes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011699
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026