FRN — Pump, Infusion Class II
FDA product code FRN covers "Pump, Infusion", a Class II medical device regulated under 21 CFR 880.5725. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FRN
- Device Class
- Class II
- Regulation Number
- 880.5725
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253703 | Deka R And D | RemunityPRO+ Pump for Remodulin® (treprostinil) Injection | Jul 24, 2026 |
| K252015 | Koru Medical Systems | FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubin | Jan 28, 2026 |
| K251640 | Baxter Healthcare Corporation | SIGMA Spectrum Infusion Pump with Master Drug Library | Jul 28, 2025 |
| K251636 | Baxter Healthcare Corporation | Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) | Jul 28, 2025 |
| K242752 | Iradimed Corporation | MRidium 3870 MRI Infusion Pump System (3870) | May 28, 2025 |
| K243855 | Carefusion 303 | BD Alaris Infusion System with Guardrails Suite MX | Apr 25, 2025 |
| K242114 | Icu Medical | Plum Solo Precision IV Pump | Apr 2, 2025 |
| K242115 | Icu Medical | Plum Duo Precision IV Pump | Apr 2, 2025 |
| K250357 | Deka Research And Development | RemunityPRO Pump for Remodulin® (treprostinil) Injection | Mar 11, 2025 |
| K241736 | Deka Research And Development | Remunity 2.0 Pump for Remodulin (treprostinil) Injection | Jan 16, 2025 |
| K242735 | Belmont Medical Technologies | Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Inf | Dec 23, 2024 |
| K242660 | Zevex | Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curli | Oct 3, 2024 |
| K242390 | Baxter Healthcare Corporation | Novum IQ Syringe Pump (40800BAXUS) | Sep 5, 2024 |
| K232793 | Zevex | Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curli | May 17, 2024 |
| K211122 | Baxter Healthcare Corporation | Novum IQ Large Volume Pump | Mar 29, 2024 |
| K231918 | Koru Medical Systems | Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate | Nov 3, 2023 |
| K230083 | Medovate Limited | SAFIRA | Oct 31, 2023 |
| K223607 | Icu Medical | Plum Duo Infusion System | Aug 24, 2023 |
| K211218 | Carefusion 303 | BD Alaris System with Guardrails Suite MX v12.1.2 | Jul 21, 2023 |
| K230022 | Baxter Healthcare Corporation | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library | Mar 31, 2023 |