# K260128: BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes

- Pathway: 510(k) (Special)
- Applicant: Becton, Dickinson and Company
- Decided: Apr 15, 2026 after 89 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K875117 (1988). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022426: BD Preset Blood Collection Syringe, BD a-Line Blood Collection Syringe, Models 365313, 365323,365316,365356,365373,36538, Becton, Dickinson & CO (2002) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K260128
Methodology: https://510kreport.com/methodology