BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube— 510(k) K252378
Substantially EquivalentBecton, Dickinson and Company
FDA 510(k) clearance K252378 for BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube, Substantially Equivalent on 2026-04-10. Applicant: Becton, Dickinson and Company. Device class: 2.
Summary
BD MiniDraw is a capillary blood collection system, cleared here with a MiniDraw SST capillary blood collection tube. Product code JKA covers blood collection tubes, vials, and serum separator systems.
Class II, 21 CFR 862.1675. The Clinical Chemistry panel reviewed it as a Traditional 510(k).
Becton, Dickinson and Company filed from Franklin Lakes, New Jersey. Review took 254 days (July 30, 2025 to April 10, 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
- 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.