# K922997: Via 1-01 Infusion Pump/Blood Chem. Syst. -- Mod.

- Pathway: 510(k) (Traditional)
- Applicant: Via Medical Corp.
- Decided: Jan 11, 1994 after 568 days
- Product code: LZF (Pump, Infusion, Analytical Sampling)
- Device class: 2
- Regulation: 21 CFR 880.5725
- 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
- May 24, 2013 · Class II · Z-1531-2013: International Biomedical has received reports of interference between the collection bag and the extension set connectors. Evaluation of the affected components indicates that the collection bag conne

Source page: https://510kreport.com/device/K922997
Methodology: https://510kreport.com/methodology