BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes— 510(k) K252040
Substantially EquivalentBecton, Dickinson and Company
FDA 510(k) clearance K252040 for BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes, Substantially Equivalent on 2026-03-13. Applicant: Becton, Dickinson and Company. Device class: 2.
Summary
Becton, Dickinson and Company's record covers BD Vacutainer® Plasma Separator Tubes (PST) and BD Vacutainer® Sodium Heparin Blood Collection Tubes. Both are filed under JKA, blood collection tubes, vials, systems and serum separators.
Class II, 21 CFR 862.1675. Clinical Chemistry is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Becton, Dickinson and Company filed from Franklin Lakes, New Jersey. Review took 256 calendar days (June 30, 2025 to March 13, 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
- Traditional
- 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
- K260128 — BD Preset and BD A-Line Arterial Blood Collection Syringes
- 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
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.