# K963136: Pacer Model 100 Infusion Controller

- Pathway: 510(k) (Traditional)
- Applicant: Health Watch, Inc.
- Decided: Oct 10, 1997 after 423 days
- Product code: LDR (Controller, Infusion, Intravascular, Electronic)
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Pacer Model 100 Infusion Controller is indicated for use in: 1. The delivery if Intravenous (parenteral) fluids where positive pressure (above 36" of water) is not required. 2. The delivery of intravenous drugs where positive pressure (above 36" of water) is not required.

Source page: https://510kreport.com/device/K963136
Methodology: https://510kreport.com/methodology