# K113227: Non-Dehp Micro-Volume Extension Set with 0.22 Micron Filter

- Pathway: 510(k) (Special)
- Applicant: Baxter Healthcare Corp
- Decided: Dec 8, 2011 after 37 days
- Product code: FPB (Filter, Infusion Line)
- 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: 1 generation back to K860746 (1986). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K860746: Auto Syringe Micro Vol Ext Set W/Air Vent Filter, Travenol Laboratories, S.A. (1986) Summary page 1.

## Indications for use
The I.V. extension set with a 0.22 micron air venting filter is indicated for the administration of fluid to a patient's vascular system and for the removal of air and particulate matter.

Source page: https://510kreport.com/device/K113227
Methodology: https://510kreport.com/methodology