510(k) · Cleared
Recalled · Class II · 2024Greiner Vacutte Blood Collection Tube W/ Clot Activator & Gel Separator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Greiner America, Inc. · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Aug 30, 1996 as substantially equivalent to K921806 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1992) after a 182-day review. Its family tree reaches back 1 generation to 1992. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Aug 30, 1996
- Review
- 182 days
- Class
- Class II
- Product code
- JKA
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K921806 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK921806 Vacutainer (R) Brand SST (R) and Cat TubesBd Becton Dickinson Vacutainer Systems Preanalytic · 1992 · Recalled
- This deviceK960858 Greiner Vacutte Blood Collection Tube W/ Clot Activator & Gel…Greiner America, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK983952 Greiner Vacuette Blood Collection TubeGreiner Meditech, Inc. · 1998 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K983952Greiner Vacuette Blood Collection TubeGreiner Meditech, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K921806 | Vacutainer (R) Brand SST (R) and Cat Tubes | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992 | 2 |
| 0 (this device) | K960858 | Greiner Vacutte Blood Collection Tube W/ Clot Activator & Gel Separator | Greiner America, Inc. | 1996 | — |
| +1 | K983952 | Greiner Vacuette Blood Collection Tube | Greiner Meditech, Inc. | 1998 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 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 |
|---|---|---|---|
| * | K921806 | Vacutainer (R) Brand SST (R) and Cat TubesSummary page 1…se in holding and separating blood serum from the cellular components of blood. Greiner is claiming substantial equivalence to Becton Dickinson's Vacutainer® SST tubes (K921806). Both blood collection tubes have the same intended use and contain the same stopper material, clot activator and separator. The… | 1992 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K983952 | Greiner Vacuette Blood Collection Tube | 1998 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 14, 2024 | Class II | Z-2375-2024 | Employee error | The firm received reports that some blood collection tubes have experienced issues with clotting and poor separation due to missing additive. The failure of the device would likely require sample recollection which could result in a delay… |
| Jul 28, 2005 | Not classified | Z-0086-06 | Other | Serum Blood Collection tubes found with excess of Blood Clot Accelerator (BCA) solution. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K983952 (Greiner Meditech, Inc., 1998) has gone furthest, with 0 descendants of its own.
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?
The product is intended for use in holding and separating blood serum from the cellular components of blood.
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/K960858 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960858: Greiner Vacutte Blood Collection Tube W/ Clot Activator & Gel Separator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960858
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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