# K252506: BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached Holder

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Apr 10, 2026 after 245 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K970259 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980414: Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer Brand Blood Collection Set, Bd Becton Dickinson Vacutainer Systems Preanalytic (1998) Summary page 6.

## Indications for use
The BD Vacutainer® Safety-Lok™ Blood Collection Set is a sterile, multi‑sample, single-use fixed winged blood collection set intended for use in the general population by healthcare professionals experienced in phlebotomy for venipuncture to obtain blood specimens from patients, including those with difficult vein access who may have small, fragile, and/or non-palpable veins, into evacuated blood collection tubes and/or blood culture bottles. When used without the male Luer adapter, the device allows the clinician to obtain a blood specimen from the female Luer connector with a syringe, if necessary. The device can be used by healthcare professionals with infusion experience for short-term, single infusions with consideration given to patient size and appropriateness for the solution being infused. The device is not to be left in place and is to remain under the direct supervision of a clinician. The safety shield is designed to mitigate the possibility of an accidental needlestick injury if manually activated after use.

Source page: https://510kreport.com/device/K252506
Methodology: https://510kreport.com/methodology