BD Preset and BD A-Line Arterial Blood Collection Syringes— 510(k) K260128
Substantially EquivalentBecton, Dickinson and Company
FDA 510(k) clearance K260128 for BD Preset and BD A-Line Arterial Blood Collection Syringes, Substantially Equivalent on 2026-04-15. Applicant: Becton, Dickinson and Company. Device class: 2.
Summary
The BD Preset and BD A-Line Arterial Blood Collection Syringes, from Becton, Dickinson and Company, are filed under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection).
Class II, 21 CFR 862.1675. It came in as a Special 510(k), and Clinical Chemistry is both the classification panel and the review panel.
Becton, Dickinson and Company filed from Franklin Lakes, New Jersey. Review took 89 calendar days (January 16 to April 15, 2026).
Clearance details
- Applicant
- Becton, Dickinson and Company
- Product code
- Product code JKA
- Device class
- Class 2
- Regulation
- 21 CFR 862.1675
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Franklin Lakes, NJ, US
Recent devices under product code JKA
view all- K262242 — Profoject Safe Push Button Blood Collection Sets
- K260857 — Sol-Guard Safety Pull Button Collection Set; Sol-Guard XtraThin Safety Pull-Button Blood Collection Set
- K252344 — BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST)
- K262215 — Profoject Safety Sliding Blood Collection Set
- K252899 — Female Culture Device; Male Culture Device; Transfer Device; Access Device
More clearances from Becton, Dickinson and Company
view all- K262163 — BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth
- K252378 — BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube
- K252506 — BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder
- K260184 — Onclarity Self-Collection Kit
- K252040 — BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes
Adverse events under product code JKA
product code JKA- Injury
- 455
- Malfunction
- 26,686
- Other
- 4
- Total
- 27,145
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.