BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder— 510(k) K252506
Substantially EquivalentBecton, Dickinson and Company
FDA 510(k) clearance K252506 for BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder, Substantially Equivalent on 2026-04-10. Applicant: Becton, Dickinson and Company.
Summary
The BD Vacutainer Safety-Lok Blood Collection Set is a butterfly-style phlebotomy device with an integrated needle-stick prevention mechanism. Product code JKA covers evacuated blood collection systems; the "safety" designation and pre-attached holder variant reflect OSHA-driven sharps-safety requirements that have shaped phlebotomy hardware design since the early 2000s.
Clinical Chemistry panel, Traditional 510(k). This looks like a line-extension or minor variant clearance rather than a new device — BD files on the Vacutainer line regularly to cover packaging configurations, needle gauge options, and labeling updates.
Becton Dickinson out of Franklin Lakes, NJ. JKA is among BD's most-filed product codes. Review clock around eight months.
Clearance details
- Applicant
- Becton, Dickinson and Company
- Product code
- 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.