# K913308: Ivex-TPN Extension Filter Set

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jan 15, 1992 after 174 days
- Product code: FPB (Filter, Infusion Line)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (0 Class I)
- 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. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Jun 9, 2003 · Not classified · Z-0955-03: The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.

Source page: https://510kreport.com/device/K913308
Methodology: https://510kreport.com/methodology