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. Device class: 2.
Summary
The BD Vacutainer Safety-Lok Blood Collection Set is a winged "butterfly" needle set with a safety shield, cleared in two versions: standard and with a pre-attached holder. It's filed under JKA, the product code for blood collection tubes, vials, and 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. Safety-Lok has been sold for years, so this looks like a configuration or labeling update to an existing line. Review took 245 days (August 8, 2025 to April 10, 2026).
Clearance details
- Applicant
- Becton, Dickinson and Company
- Product code
- 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
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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.