510(k) · Cleared
ClearedVacutainer Brand Blood Collection Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton Dickinson Vacutainer Systems · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Sep 22, 1998 as substantially equivalent to K896514 (Radiometer America, Inc., 1990) and 1 other predicate after a 34-day review. Its family tree reaches back 1 generation to 1988. 3 later devices descend from it.
- Decided
- Sep 22, 1998
- Review
- 34 days
- Class
- Class II
- Product code
- JKA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K875117 (1988). 2 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK875117 Ciba Corning Balanced Heparin for CA++Ciba Corning Diagnostics Corp. · 1988
- This deviceK982922 Vacutainer Brand Blood Collection SyringeBecton Dickinson Vacutainer Systems · 1998
- Descendant · cites it directly · 2 of its ownK022426 BD Preset Blood Collection Syringe, BD a-Line Blood Collection…Becton, Dickinson & CO · 2002
- Descendant · 2 generations on · 0 of its ownK260128 BD Preset™ and BD A-Line™ Arterial Blood Collection SyringesBecton, Dickinson and Company · 2026
- Descendant · 2 generations on · 0 of its ownK202446 BD Preset Syringe & BD A-Line SyringeBecton, Dickinson and Company · 2020
Most influential descendants
Showing 3 of 3 · See all- K022426BD Preset Blood Collection Syringe, BD a-Line Blood Collection Syringe, Models 365313…Becton, Dickinson & CO · 2002 · cites it directly2descendants
- K260128BD Preset™ and BD A-Line™ Arterial Blood Collection SyringesBecton, Dickinson and Company · 2026 · 2 generations on0descendants
- K202446BD Preset Syringe & BD A-Line SyringeBecton, Dickinson and Company · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K875117 | Ciba Corning Balanced Heparin for CA++ | Ciba Corning Diagnostics Corp. | 1988 | — |
| 0 (this device) | K982922 | Vacutainer Brand Blood Collection Syringe | Becton Dickinson Vacutainer Systems | 1998 | — |
| +1 | K022426 | BD Preset Blood Collection Syringe, BD a-Line Blood Collection Syringe, Models… | Becton, Dickinson & CO | 2002 | — |
| +2 | K260128 | BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes | Becton, Dickinson and Company | 2026 | — |
| +2 | K202446 | BD Preset Syringe & BD A-Line Syringe | Becton, Dickinson and Company | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2020 | 1 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K896514 | QS90 Smooth E Arterial Blood SamplerSummary page 4…evice K-Number Clearance Date Becton Dickinson Becton Dickinson |N/A Exempt from premarket Division Division Arterial notification Blood Gas Syringe RADIOMETER Smooth E™ K896514 unknown AMERICA INC. Arterial Blood Sampler CHIRON/Diagnostics | VACUTAINER K875117 2/29/88 RapidLyte™ Arterial Brand Safety Bloo… | 1990 |
| * | K875117 | Ciba Corning Balanced Heparin for CA++Summary page 4…market Division Division Arterial notification Blood Gas Syringe RADIOMETER Smooth E™ K896514 unknown AMERICA INC. Arterial Blood Sampler CHIRON/Diagnostics | VACUTAINER K875117 2/29/88 RapidLyte™ Arterial Brand Safety Blood Sampler Blood Collection Assembly SIS N} 3/ \alaR | § Keith M. Smith Senior Regu… | 1988 |
| * | — | Becton Dickinson Division Arterial Blood Gas Syringe Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022426 | BD Preset Blood Collection Syringe, BD a-Line Blood Collection Syringe, Models 365313… | 2002 | 2 |
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?
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 VACUTAINER Brand Blood Collection Syringe is intended to collect whole blood specimens for diagnostic testing which may include: pH, blood gases, electrolytes (including ionized calcium and magnesium), metabolytes, co-oximetry, and other tests.
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/K982922 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982922: Vacutainer Brand Blood Collection Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982922
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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