510(k) · Cleared
Recalled · Class II · 2025Greiner Vacuette Blood Collection Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Greiner Meditech, Inc. · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Dec 28, 1998 as substantially equivalent to K960858 (Greiner America, Inc., 1996) after a 53-day review. Its family tree reaches back 2 generations to 1992. It has been recalled 3 times.
- Decided
- Dec 28, 1998
- Review
- 53 days
- Class
- Class II
- Product code
- JKA
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 2 generations to K921806 (1992). No later device cites it as a predicate yet.
- Root · 2 generations backK921806 Vacutainer (R) Brand SST (R) and Cat TubesBd Becton Dickinson Vacutainer Systems Preanalytic · 1992 · Recalled
- 1 generation backK960858 Greiner Vacutte Blood Collection Tube W/ Clot Activator & Gel…Greiner America, Inc. · 1996 · Recalled
- This deviceK983952 Greiner Vacuette Blood Collection TubeGreiner Meditech, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K921806 | Vacutainer (R) Brand SST (R) and Cat Tubes | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992 | 2 |
| −1 | K960858 | Greiner Vacutte Blood Collection Tube W/ Clot Activator & Gel Separator | Greiner America, Inc. | 1996 | 2 |
| 0 (this device) | K983952 | Greiner Vacuette Blood Collection Tube | Greiner Meditech, Inc. | 1998 | — |
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? (2)
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 |
|---|---|---|---|
| * | K960858 | Greiner Vacutte Blood Collection Tube W/ Clot Activator & Gel SeparatorSummary page 1…ESS Greiner';\/leditech, Inc. (“Greiner”) is submitting a labeling change to its already approved VACUETTE® blood collection tube with clot activator and gel separator (K960858). The Greiner VACUETTE® blood collection tube with clot activator and gel separator is an evacuated blood collection device conta… | 1996 |
| * | — | Becton Dickinson VACUTAINER® Brand plain glass blood collection tubes Named without a submission number |
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 19, 2025 | Class II | Z-0571-2026 | Labeling Change Control | Some of the Vacuette CAT Serum Separator Clot Activator tubes were manufactured without gel separator, which could yield erroneous assay results and require the patient to return to the lab for recollection or repeat testing. This may… |
| 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… |
| Nov 25, 2019 | Class II | Z-0818-2020 | Process control | The Vacuette 3.5mL Serup Sep Clot Activator Tubes may have been damaged at the cap sealing area. This may lead to a vacuum loss and tubes not filling up to the proper volume. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 4.3 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?
To collect, transport, store and process blood for testing serum in the clinical laboratory. In addition, tubes are suitable for therapeutic drug monitoring.
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/K983952 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983952: Greiner Vacuette Blood Collection Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983952
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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