# K974778: Abbott Gemstar IV Infusion Pump

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Mar 17, 1998 after 85 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 3 (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’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Apr 1, 2003 · Not classified · Z-0792-03: Products contain software deficiencies which could allow over infusion thereby administering excess medication.
- Apr 1, 2003 · Not classified · Z-0794-03: Products contain software deficiencies which could allow over infusion thereby administering excess medication.
- Apr 1, 2003 · Not classified · Z-0793-03: Products contain software deficiencies which could allow over infusion thereby administering excess medication.

## Indications for use
The subject device, the GEMSTAR Infusion Pump, is indicated for intravenous, arterial, short-term epidural, and parenteral administration of general .V. fluids, medications, nutritional fluids, and blood/blood products to patients in hospital and home care environments.

Source page: https://510kreport.com/device/K974778
Methodology: https://510kreport.com/methodology