510(k) · Cleared
ClearedBD Preset Blood Collection Syringe, BD a-Line Blood Collection Syringe, Models 365313, 365323,365316,365356,365373,36538
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson & CO · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Aug 8, 2002 as substantially equivalent to K982922 (Becton Dickinson Vacutainer Systems, 1998) after a 14-day review. Its family tree reaches back 2 generations to 1988. 2 later devices descend from it.
- Decided
- Aug 8, 2002
- Review
- 14 days
- Class
- Class II
- Product code
- JKA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K875117 (1988). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK875117 Ciba Corning Balanced Heparin for CA++Ciba Corning Diagnostics Corp. · 1988
- 1 generation backK982922 Vacutainer Brand Blood Collection SyringeBecton Dickinson Vacutainer Systems · 1998
- This deviceK022426 BD Preset Blood Collection Syringe, BD a-Line Blood Collection…Becton, Dickinson & CO · 2002
- Descendant · cites it directly · 0 of its ownK260128 BD Preset™ and BD A-Line™ Arterial Blood Collection SyringesBecton, Dickinson and Company · 2026
- Descendant · cites it directly · 0 of its ownK202446 BD Preset Syringe & BD A-Line SyringeBecton, Dickinson and Company · 2020
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 |
|---|---|---|---|---|---|
| −2 | K875117 | Ciba Corning Balanced Heparin for CA++ | Ciba Corning Diagnostics Corp. | 1988 | — |
| −1 | K982922 | Vacutainer Brand Blood Collection Syringe | Becton Dickinson Vacutainer Systems | 1998 | — |
| 0 (this device) | K022426 | BD Preset Blood Collection Syringe, BD a-Line Blood Collection Syringe, Models… | Becton, Dickinson & CO | 2002 | — |
| +1 | K260128 | BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes | Becton, Dickinson and Company | 2026 | — |
| +1 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K982922 | Vacutainer Brand Blood Collection SyringeSummary page 3…ce date are also identified in the table below. Manufacturer Predicate Device K-Number Clearance Date Becton VACUTAINERTM K982922 Sept. 22, 1998 Dickinson Brand Blood Collection Syringes Regulatory Affairs Specialist Be… | 1998 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 3 companies; a new generation was cleared every 10.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K260128 (Becton, Dickinson and Company, 2026) 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?
BD PresetTMand BD A-LineTMBlood Collection Syringe are intended to collect whole blood specimens for diagnostic testing which may include: pH, blood gases, electrolytes (including ionized calcium), metabolytes, co-oximetry, and other tests
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022426 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022426: BD Preset Blood Collection Syringe, BD a-Line Blood Collection Syringe, Models 365313, 365323,365316,365356,365373,36538.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022426
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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