# K083019: Gemstar SP Infusion System with Gemstar SP Infusion Suite Software

- Pathway: 510(k) (Traditional)
- Applicant: Hospira, Inc.
- Decided: Oct 22, 2008 after 13 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 8 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K011442 (2001). 10 ancestors in all.
No later device cites it as a predicate yet.
4 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060806: Hospira Gemstar Infusion Pump System, 7 Therapy, Model 13087; 6 Therapy, Model 13086; Pain Management, Model 13088, Hospira, Inc. (2006) Summary page 1.
- K042800: Lifecare Pca Infusion System with Hospira Mednet Software, Hospira, Inc. (2004) Summary page 1.

## Recalls of this device
- Mar 21, 2013 · Class II · Z-1116-2013: During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medication resulting in over-infusion.
- Mar 21, 2013 · Class II · Z-1117-2013: During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medication resulting in over-infusion.
- Mar 18, 2013 · Class I · Z-1159-2013: Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy's parameters and causes an 11/004 error resulting in the pump not being able to be used.
- Mar 18, 2013 · Class I · Z-1160-2013: Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy's parameters and causes an 11/004 error resulting in the pump not being able to be used.
- Mar 18, 2013 · Class I · Z-1170-2013: Pump shutting off during use without warning.
- Mar 15, 2013 · Class I · Z-0350-2014: The proximal and distal pressure sensor calibration can drift resulting in the pump failing the Proximal or Distal Occlusion Operational Test, as described in the GemStar Technical Service Manual, or 
- 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
- Mar 23, 2011 · Not classified · Z-1999-2011: The software enables programming of the GemStar device for a Bolus Lower Lockout Limit outside of the hard limits entered into the GemStar SP Infusion Suite Database PC application.

## Indications for use
The GemStarTM SP Infusion System with GemStar T M SP Infusion Suite software is intended for use in intravenous, arterial, subcutaneous, shod 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/K083019
Methodology: https://510kreport.com/methodology