510(k) · Cleared
ClearedBD Preset™ and BD A-Line™ Arterial Blood Collection Syringes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson and Company · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Apr 15, 2026 as substantially equivalent to K022426 (Becton, Dickinson & CO, 2002) after an 89-day review. Its family tree reaches back 3 generations to 1988.
- Decided
- Apr 15, 2026
- Review
- 89 days
- Class
- Class II
- Product code
- JKA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K875117 (1988). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK875117 Ciba Corning Balanced Heparin for CA++Ciba Corning Diagnostics Corp. · 1988
- 2 generations backK982922 Vacutainer Brand Blood Collection SyringeBecton Dickinson Vacutainer Systems · 1998
- 1 generation backK022426 BD Preset Blood Collection Syringe, BD a-Line Blood Collection…Becton, Dickinson & CO · 2002
- This deviceK260128 BD Preset™ and BD A-Line™ Arterial Blood Collection SyringesBecton, Dickinson and Company · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K875117 | Ciba Corning Balanced Heparin for CA++ | Ciba Corning Diagnostics Corp. | 1988 | — |
| −2 | 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 | — |
| 0 (this device) | K260128 | BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes | Becton, Dickinson and Company | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 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 |
|---|---|---|---|
| * | K022426 | BD Preset Blood Collection Syringe, BD a-Line Blood Collection Syringe, Models 365313…Summary page 5…fication Regulation: 21 CFR § 862.1675 Review Panel: Clinical Chemistry Class: II Product Code: JKA Predicate Device: BD Preset™ and BD A-Line™ Blood Collection Syringe (K022426) 510(k) Reference: K022426 Classification Name: Blood Specimen Collection Device; 21 CFR §862.1675 1mL BD Preset™… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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 38 years and passes through 4 companies; a new generation was cleared every 10.6 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K022426.
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. 2026, this device’s year, is highlighted.
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 BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes are sterile, single-use, in vitro diagnostic medical devices specifically intended to be used for the collection and containment of whole blood specimens for the purpose of in vitro diagnostic testing which may include: pH, blood gases, electrolytes (including ionized calcium), metabolites, co-oximetry. The device is intended to be used by trained healthcare professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260128 · printed Nov 5, 2026
Cite this page
510(k) Report. “K260128: BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K260128
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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