# K060352: Health Line International Corporations,S IV Administrative Sets

- Pathway: 510(k) (Traditional)
- Applicant: Health Line International Corporation
- Decided: May 31, 2006 after 107 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.
13 later devices descend from it; 1 cites it directly.
2 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites 2 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K0925126: Baxter. Number could not be read
- K089098: Baxter. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K120685: Zyno Medical Administration Set (2012), 12 descendants of its own
- K151151: U & U Intravascular Administration Set (2015), 5 descendants of its own
- K232316: DEKA Infusion System, DEKA Administration Set (2024), 1 descendant of its own
- K230343: ProSeal™ Closed System Administration Set (2023), 1 descendant of its own
- K173361: IV Administration Set (2018), 1 descendant of its own

## Indications for use
The indicated use of health Line International Corporation's IV Administration Sets and Extensions Sets is for administration of fluids from a container to the patents vascular system.

Source page: https://510kreport.com/device/K060352
Methodology: https://510kreport.com/methodology