# K921674: Lifeport Infusion Set and Infusion Set W/ Y Site

- Pathway: 510(k) (Traditional)
- Applicant: Strato Medical Corp.
- Decided: Sep 23, 1992 after 168 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.
25 later devices descend from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K013871: Lifeguard Safety Infusion Set (2002), 24 descendants of its own
- K062414: Vortex CT Port Access System and Lifeguard Safety Infusion Set (2007), 20 descendants of its own
- K073050: Safestep Max Power-Injectable Infusion Set (2008), 13 descendants of its own
- K170897: Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site (2017), 6 descendants of its own
- K072375: Smartport CT MP Port Access System and Lifeguard CT Safety Infusion Set (2007), 5 descendants of its own

Source page: https://510kreport.com/device/K921674
Methodology: https://510kreport.com/methodology