K252378
Substantially EquivalentBD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube
The BD MiniDraw Capillary Blood Collection System with SST tube is a finger-stick blood collection device targeting near-patient workflows where a full venous draw isn't practical. Product code JKA is the broad category for blood-collection evacuated tubes and associated hardware — BD dominates this category by volume.
Clinical Chemistry panel, Traditional 510(k). The SST (serum separator tube) variant means the tube is designed to produce serum samples for downstream chemistry testing, not just whole blood. The "MiniDraw" branding suggests lower-volume sampling, likely aimed at pediatric or point-of-care applications where venipuncture is burdensome.
Becton Dickinson is the global incumbent in JKA — they file on this code multiple times per year across the tube and needle portfolios. Nine-month clock is typical.
- Applicant
- Becton, Dickinson and Company
- Product code
- JKA
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Franklin Lakes, NJ, US
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.