510(k) · Cleared
Recalled · Class II · 2014Vacutainer (R) Brand SST (R) and Cat Tubes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bd Becton Dickinson Vacutainer Systems Preanalytic · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Apr 29, 1992 after a 14-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 29, 1992
- Review
- 14 days
- Class
- Class II
- Product code
- JKA
- Recalls
- 2
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK921806 Vacutainer (R) Brand SST (R) and Cat TubesBd Becton Dickinson Vacutainer Systems Preanalytic · 1992
- Descendant · cites it directly · 1 of its ownK960858 Greiner Vacutte Blood Collection Tube W/ Clot Activator & Gel…Greiner America, Inc. · 1996 · Recalled
- Descendant · 2 generations on · 0 of its ownK983952 Greiner Vacuette Blood Collection TubeGreiner Meditech, Inc. · 1998 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K921806 | Vacutainer (R) Brand SST (R) and Cat Tubes | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992 | — |
| +1 | K960858 | Greiner Vacutte Blood Collection Tube W/ Clot Activator & Gel Separator | Greiner America, Inc. | 1996 | 2 |
| +2 | K983952 | Greiner Vacuette Blood Collection Tube | Greiner Meditech, Inc. | 1998 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K960858 | Greiner Vacutte Blood Collection Tube W/ Clot Activator & Gel Separator | 1996 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 23, 2014 | Class II | Z-2630-2014 | Storage | Products were held at improper storage temperature |
| Aug 20, 2004 | Not classified | Z-0052-05 | Other | "Please be aware tht this not a new recall. The firm has taken action; but, due to administrative issues additional products are now being classified by the agency". There is an apparent bias in the determination of Total T3, Total T4… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K960858 (Greiner America, Inc., 1996) has gone furthest, with 1 descendant 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 | — |
https://510kreport.com/device/K921806 · printed Nov 4, 2026
Cite this page
510(k) Report. “K921806: Vacutainer (R) Brand SST (R) and Cat Tubes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K921806
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026