# K111351: Truecare Biomedix Intravascular Administration Set, Truecare Biomedix Extension Set

- Pathway: 510(k) (Abbreviated)
- Applicant: Us Infusion Dba Truecare Biomedix
- Decided: Sep 29, 2011 after 139 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: 2 generations back to K925465 (1993). 2 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050906: Vitalcare I.V. Administration Set, Vitalcare Group, Inc. (2005) Summary page 2.

## Most influential descendants
- K121803: Intravascular Administration Set (2012), 4 descendants of its own
- K230992: DJF Intravascular Administration Set (2023), 0 descendants of its own
- K223645: I.V. Administration Set, I.V. Extension 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

## Indications for use
Truecare Biomedix Intravascular administration set intended use is to deliver sterile, infusion fluid from a container to the patient with or without flow control features. Truecare Biomedix 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/K111351
Methodology: https://510kreport.com/methodology