Multi Drug Infusion System
FDA 510(k) K904048 · I-Flow Corp.
510(k) numberK904048
Submission
- Device name
- Multi Drug Infusion System
- Applicant
- I-Flow Corp.
Irvine, CA, US - Received
- September 4, 1990
- Decision date
- October 1, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
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|---|---|---|---|
| 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 |
|---|---|---|
| K131249 | On-Q Painbuster, On-Q C-Bloc, Homepump Eclipse, Homepump C-SeriesMEB · Traditional | 02/03/2014SE |
| K063530 | On-Q, Painbuster, C-Bloc, Select-A-Flow, Ondemand, Homepump, Eclipse, C-Series, One-Step…MEB · Special | 01/26/2007SE |
| K063234 | On-Q IntroducersBSO · Abbreviated | 11/21/2006SE |
| K051401 | On-Q Catheter, On-Antimicrobial Catheter, Soaker Catheter, I-Flow CatheterBSO · Traditional | 11/30/2005SE |
| K052117 | I-Flow Elastomeric Pump (On-Q, Painbuster, C-Block, Homepump, Easypump)MEB · Special | 09/09/2005SE |
| K043456 | Modification to Soaker CatheterBSO · Special | 01/11/2005SE |
| K040337 | I-Flow Elastomeric Pump (On-Q, Painbuster, C-Bloc, Homepump)MEB · Traditional | 05/24/2004SE |
| K023883 | Homepump, Eclipse, C-Series, Painbuster, C-Bloc, On-Q, Easypump, KvoMEB · Special | 12/20/2002SE |
| K023827 | Paragon Infusion System with BolusFRN · Special | 12/13/2002SE |
| K023318 | I-Flow Elastomeric Pump with BolusMEB · Special | 10/18/2002SE |
Questions and answers
When was Multi Drug Infusion System cleared by the FDA?
Multi Drug Infusion System (K904048) received a 510(k) decision of Substantially Equivalent on October 1, 1990, 27 days after the submission was received.
What is the product code of K904048?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.