# K946168: Ivac Enteral Admin. Sets, Ivac Infusion Pumps

- Pathway: 510(k) (Traditional)
- Applicant: Ivac Corporation
- Decided: Mar 21, 1996 after 458 days
- Product code: LZH (Pump, Infusion, Enteral)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- 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. The FDA summary names its predicate without a number.
- (no number) IVAC 72 Series Enteral Administration Sets: named in the summary without a submission number
- (no number) Model 7100 Infusion Pump: named in the summary without a submission number

## Indications for use
The intended use for the IVAC enteral administration sets is to provide nutrition to patients who have an impaired ability to orally ingest their food. The pumping segment or cassette of the enteral administration set interacts with the pumping mechanism of the infusion pump to regulate fluid flow at the desired rate.

Source page: https://510kreport.com/device/K946168
Methodology: https://510kreport.com/methodology