# K994039: Abbott Gemstar I.V. Infusion Pump-7 Therapy Configuration, Abbott Gemstar I.V. Infusion Pump-6 Therapy Configuration, AB

- Pathway: 510(k) (Special)
- Applicant: Abbott Laboratories
- Decided: Dec 22, 1999 after 23 days
- Product code: FRN (Pump, Infusion)
- 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 GemStar™ V. Infusion Pump intended use is: The GemStar™ Infusion Pump is indicated for intravenous, arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to patients in hospital and home care environments.

Source page: https://510kreport.com/device/K994039
Methodology: https://510kreport.com/methodology