Gemstar Sp Infusion System With Gemstar Sp Infusion Suite Software
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K083019 FDA 510(k)
- FDA Product Code
- FRN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5725 FDA 510(k)
- Regulation Number
- 880.5725 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The device is a pump, infusion, as defined by its device type and nomenclature. It is the Gemstar SP Infusion System with Gemstar SP Infusion Suite Software, a programmable infusion pump system designed for intravenous therapy delivery.
The system includes a PC-based software suite used to program the pump and enforce dosing limits. The pump features a user interface for weight- and medication-based programming, displays operational status and alarms, and is intended for use by healthcare professionals, caregivers, and patients. It is supplied as a reusable system with associated software and is regulated under FDA 510(k) clearance K083019, classified as a Class II device under regulation number 880.5725.
Frequently asked questions
What is the Gemstar SP Infusion System used for?
The Gemstar SP Infusion System is designed for intravenous therapy delivery, enabling precise programming of infusion rates based on patient weight and medication parameters to support safe and accurate fluid and drug administration in clinical and home care settings.
How is the Gemstar SP Infusion System supplied and is it reusable?
The system is supplied as a reusable infusion pump system that includes the pump hardware and the Gemstar SP Infusion Suite Software, which is used to program the pump and enforce dosing limits; it is intended for repeated use with appropriate cleaning and maintenance between patients.
Who is intended to operate the Gemstar SP Infusion System?
The system is intended for use by healthcare professionals, caregivers, and patients, featuring a user interface that supports weight- and medication-based programming, displays operational status and alarms, and allows for safe operation across different care environments.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: GEMSTAR SP INFUSION SYSTEM WITH GEMSTAR SP INFUSION SUITE SOFTWARE ..., Hospira Gemstar - Series Infusion Pump | PDF | Intravenous Therapy ..., HOSPIRA GEMSTAR SERIES SYSTEM OPERATING MANUAL Pdf Download
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K083019 | Class II | Active |
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Manufacturer
- Manufacturer
- Hospira, Inc.
Sources (1)
- FDA 510(k) K083019 24 fields · synced Sep 22, 2026