# K003854: Intravascular Administration Set

- Pathway: 510(k) (Traditional)
- Applicant: Infusion Devices, Inc.
- Decided: Feb 5, 2001 after 54 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.
5 later devices descend from it; 1 cites it directly.
0 of 6 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
- K082710: Safechild Enteral Feeding Tube and Accessories and Feeding Tube Extension Set (2009), 4 descendants of its own
- K092628: Enteral Feeding Tube and Accessories, Feeding Tube Extension Set (2010), 2 descendants of its own
- K162340: Stomach Tube (2017), 0 descendants of its own
- K112863: Enteral Administration Set with Solution Container, Enteral Administration Set, Enteral Extension Set with Minitube Conn (2012), 0 descendants of its own
- K100700: Med-RX Pediatric Feeding Tubes and Accessories (2010), 0 descendants of its own

Source page: https://510kreport.com/device/K003854
Methodology: https://510kreport.com/methodology