# K965202: Vacutainer Brand Safety-Lok Blood Collection Set

- Pathway: 510(k) (Traditional)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: Feb 10, 1997 after 46 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
No predicates in its family tree.
139 later devices descend from it; 3 cite it directly.
0 of 140 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) VACUTAINER® Brand Safety-Lok™ Blood Collection Set: named in the summary without a submission number

## Most influential descendants
- K021475: BD Single Lumen Needle, Syringe and Blood Collection Set (2002), 100 descendants of its own
- K070440: BD Hypoint Needle (2007), 91 descendants of its own
- K072739: Jierui Syringes and Needles (2008), 78 descendants of its own
- K110421: Disposable Insulin Syringe (2011), 36 descendants of its own
- K112057: KDL Syringes and Needle (2011), 31 descendants of its own

## Indications for use
A needle and attached tubing for venipuncture and the collection of blood specimens from patients. Includes a safety shield to minimize the possibility of needlesticks.

Source page: https://510kreport.com/device/K965202
Methodology: https://510kreport.com/methodology