# K980414: Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer Brand Blood Collection Set

- Pathway: 510(k) (Traditional)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: Mar 3, 1998 after 28 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K970259 (1997). 1 ancestor in all.
47 later devices descend from it; 12 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970259: E-Z Set Infusion Set/Saf-T E-Z Set Infusion Set, Becton Dickinson Vascular Access, Inc. (1997) Summary page 3.

## Most influential descendants
- K011984: BD Vacutainer Push Button Blood Colection Set (2001), 23 descendants of its own
- K022875: Modification to BD Vacutainer Push Button Blood Collection Set (2002), 18 descendants of its own
- K030573: BD Vacutainer Push Button Blood Collection Set, Models 367338, 367344, 367336, 367342, 367335, 367341 (2003), 17 descendants of its own
- K153309: BD Vacutainer UltraTouch Push Button Blood Collection Set (2016), 6 descendants of its own
- K192247: Steripath Gen2 Blood Collection System (2020), 5 descendants of its own

## Recalls of this device
- Mar 20, 2007 · Not classified · Z-0777-2007: The BD Vacutainer Safety-Lok Blood Collection Set with Preattached Holder has a problem where the non-patient needle (in the holder) may become separated from the hub and remain the stopper of an evac

## Indications for use
THE VACUTAINER® BRAND BLOOD COLLECTION SETS AND SAFETY-LOK™ BLOOD COLLECTION SET IS A WINGED BLOOD COLLECTION NEEDLE AND FLEXIBLE TUBING FOR VENIPUNCTURE TO COLLECT BLOOD SPECIMENS FROM PATIENTS OR MONITORING BLOOD PRESSURE. THE SAFETY-LOK™ BLOOD COLLECTION SET ALSO CONTAINS A NEEDLE SAFETY SHIELD WHICH MINIMIZES THE POSSIBILITY OF NEEDLESTICKS IF MANUALLY ACTIVATED FOLLOWING BLOOD COLLECTION. THE VACUTAINER® BRAND BLOOD COLLECTION SETS AND SAFETY-LOK™ BLOOD COLLECTION SET IS ALSO RECOMMENDED FOR USE IN PATIENTS WITH SMALL VEINS. THE VACUTAINER® BRAND BLOOD COLLECTION SETS AND SAFETY-LOK™ BLOOD COLLECTION SET IS ALSO INDICATED FOR THE INTRAVENOUS ADMINISTRATION OF FLUIDS AND MAY BE USED FOR ANY PATIENT POPULATION WITH CONSIDERATION GIVEN TO PATIENT SIZE, APPROPRIATENESS FOR THE SOLUTION BEING INFUSED AND DURATION OF THERAPY.

Source page: https://510kreport.com/device/K980414
Methodology: https://510kreport.com/methodology