# K030385: IV Add-on Filter Administration Set with and Without Y Connect or Needleless Access Connector

- Pathway: 510(k) (Traditional)
- Applicant: Kawasumi Laboratories America, Inc.
- Decided: Apr 15, 2003 after 69 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K00142: Kawasaki Laboratories IV Administration Set. Number could not be read

## Indications for use
THE rV ADD-ON FILTER ADMINISTRATION SET USED TO ATTACH TO A NON FILTERED IV ADMINISTRATION SET FOR THE PURPOSE OF FILTERING SOLUTION D W G MTRAVASCULAR ADMINISTRATION. THE DEVICE MAY INCLUDE A NEELE FREE VALVE INJECTION SITE WHICH ELIMINATES THE USE OF NEEDLES TO ACCESS THE SET DURING IV ADMINISTRATTON AND AIDS IN THE PREVENTiON OF NEELDESTICK INJURIES.

Source page: https://510kreport.com/device/K030385
Methodology: https://510kreport.com/methodology