# K964853: Intravia Container, Empty

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Mar 31, 1997 after 118 days
- Product code: KPE (Container, I.V.)
- Device class: 2
- Regulation: 21 CFR 880.5025
- Recalls of this device: 3 (2 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.
1 of 1 device in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Viaflex® Empty Plastic Container: named in the summary without a submission number

## Recalls of this device
- Jul 27, 2017 · Class II · Z-0485-2018: A leak may allow for microbial contamination of the sterile fluid path.
- Sep 16, 2014 · Class I · Z-0085-2015: Particulate matter found inside the fluid path.
- Sep 16, 2014 · Class I · Z-0084-2015: Particulate matter found inside the fluid path.

## Indications for use
used for the preparation and administration of drug admixtures.

Source page: https://510kreport.com/device/K964853
Methodology: https://510kreport.com/methodology