# K970259: E-Z Set Infusion Set/Saf-T E-Z Set Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Vascular Access, Inc.
- Decided: Apr 8, 1997 after 75 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
48 later devices descend from it; 1 cites 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)
- None. The FDA summary names its predicate without a number.
- (no number) Becton Dickinson Vascular Access E-Z SET® and SAF-T E-Z SET® brand infusion sets: named in the summary without a submission number

## Most influential descendants
- K980414: Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer Brand Blood Collection Set (1998), 47 descendants of its own
- 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

## Indications for use
The intended use is to provide access to the vascular system to administer fluids intravenously. The device is also suitable for sampling blood and monitoring blood pressure.

Source page: https://510kreport.com/device/K970259
Methodology: https://510kreport.com/methodology