# K042980: Hospira Gemstar Infusion Pump System, Hospira Gemstar Connect Software

- Pathway: 510(k) (Special)
- Applicant: Hospira, Inc.
- Decided: Nov 17, 2004 after 19 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000821 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023062: Gemstar Infusion Pump System, 7 Therapy, 6 Therapy & Pain Management, Abbott Laboratories, Inc. (2002) Summary page 2.
- K000821: Abbott Gemstar I.V. Infusion Pump - 7 Therapy Configuration, 6 Therapy Configuration, 1 Therapy Configuration, Abbott Laboratories (2000) Summary page 2.

## Recalls of this device
- Mar 28, 2012 · Not classified · Z-1463-2012: Hospira has received customer reports of bolus delivery failures when using the GemStar bolus cord. Possible failures may be a result of cracked or damaged bolus cords which may result in an open or s
- Aug 1, 2011 · Not classified · Z-3107-2011: Hospira has received reports of sparking, smoking, charring and electrical shock when using the GemStar Docking Station due to fluid ingress into the docking station.

## Indications for use
The Hospira GemStar® Infusion Pump System with Hospira GemStar Connect" Software is intended for use in intravenous arterial, subcutaneous, short term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products. The indications for use include hospital, ambulatory, and home care environments. The pump must be used with sterile, dedicated, GemStar® administration sets.

Source page: https://510kreport.com/device/K042980
Methodology: https://510kreport.com/methodology