# K121803: Intravascular Administration Set

- Pathway: 510(k) (Abbreviated)
- Applicant: Acta Medical, LLC
- Decided: Dec 19, 2012 after 183 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
Longest line of descent: 3 generations back to K925465 (1993). 3 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111351: Truecare Biomedix Intravascular Administration Set, Truecare Biomedix Extension Set, Us Infusion Dba Truecare Biomedix (2011) Summary page 1.

## Most influential descendants
- K230992: DJF Intravascular Administration Set (2023), 0 descendants of its own
- K210381: I.V. Administration Set (2021), 0 descendants of its own
- K162601: Infusion Set for Single Use (2017), 0 descendants of its own
- K150513: Imed Technology Intravascular Administration Set, Imed Technology Extension Set (2015), 0 descendants of its own

## Indications for use
Acta Medical Intravascular administration set intended use is to deliver sterile, infusion fluid from a container to the patient with or without flow control features. Acta Medical infusion tubing may act as an extension of other infusion tubing in delivering intravenous fluids from a container to patient.

Source page: https://510kreport.com/device/K121803
Methodology: https://510kreport.com/methodology