Gemstar SP Infusion System with Gemstar SP Infusion Suite Software
FDA 510(k) K083019 · Hospira, Inc.
510(k) numberK083019
Submission
- Device name
- Gemstar SP Infusion System with Gemstar SP Infusion Suite Software
- Applicant
- Hospira, Inc.
Lake Forest, IL, US - Received
- October 9, 2008
- Decision date
- October 22, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- FRN – Pump, Infusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
Other 510(k)s with product code FRN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253703 | RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionFRN · Traditional | Deka R&D Corp | 07/24/2026SE |
| K252015 | FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingFRN · Traditional | Koru Medical Systems, Inc. | 01/28/2026SE |
| K251640 | SIGMA Spectrum Infusion Pump with Master Drug LibraryFRN · Traditional | Baxter Healthcare Corporation | 07/28/2025SE |
| K251636 | Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)FRN · Traditional | Baxter Healthcare Corporation | 07/28/2025SE |
| K242752 | MRidium 3870 MRI Infusion Pump System (3870)FRN · Traditional | Iradimed Corporation | 05/28/2025SE |
| K243855 | BD Alaris Infusion System with Guardrails Suite MXFRN · Traditional | Carefusion 303, Inc. | 04/25/2025SE |
| K242115 | Plum Duo Precision IV PumpFRN · Traditional | Icu Medical, Inc. | 04/02/2025SE |
| K242114 | Plum Solo Precision IV PumpFRN · Traditional | Icu Medical, Inc. | 04/02/2025SE |
| K250357 | RemunityPRO Pump for Remodulin® (treprostinil) InjectionFRN · Special | Deka Research & Development Corp. | 03/11/2025SE |
| K241736 | Remunity 2.0 Pump for Remodulin (treprostinil) InjectionFRN · Traditional | Deka Research and Development Corp. | 01/16/2025SE |
More from Deka Research and Development Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K161469 | Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleFRN · Traditional | 03/28/2017SE |
| K161036 | Hospira Extension Set, Hospira Primary SetFPA · Traditional | 01/06/2017SE |
| K160492 | Hospira Sapphire SetsMRZ · Traditional | 12/06/2016SE |
| K160870 | Hospira Administration SetsFPA · Special | 06/01/2016SE |
| K143612 | LifeCare PCA Infusion SystemMEA · Traditional | 04/08/2016SE |
| K143087 | Hospira Blood SetFPA · Traditional | 03/04/2015SE |
| K143015 | Hospira Primary SetsFPA · Traditional | 02/25/2015SE |
| K141789 | Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play Ce 3.0 Module for…FRN · Traditional | 01/16/2015SE |
| K142622 | IV AdministrationFPA · Traditional | 01/15/2015SE |
| K142974 | Extension SetsFPA · Traditional | 01/09/2015SE |
Questions and answers
When was Gemstar SP Infusion System with Gemstar SP Infusion Suite Software cleared by the FDA?
Gemstar SP Infusion System with Gemstar SP Infusion Suite Software (K083019) received a 510(k) decision of Substantially Equivalent on October 22, 2008, 13 days after the submission was received.
What is the product code of K083019?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.