# K860746: Auto Syringe Micro Vol Ext Set W/Air Vent Filter

- Pathway: 510(k) (Traditional)
- Applicant: Travenol Laboratories, S.A.
- Decided: Apr 7, 1986 after 39 days
- Product code: FPB (Filter, Infusion Line)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K113227: Non-Dehp Micro-Volume Extension Set with 0.22 Micron Filter (2011), 0 descendants of its own

## Recalls of this device
- Oct 17, 2002 · Not classified · Z-0520-03: The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
- Oct 17, 2002 · Not classified · Z-0521-03: The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.

Source page: https://510kreport.com/device/K860746
Methodology: https://510kreport.com/methodology