FRN
- Product code
- FRN
- Device name
- Pump, Infusion
- Device class
- Class 2
- 21 CFR
- 21 CFR 880.5725
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 17
- Summaries archived here
- 16 (direct download)
- 510(k) clearances (all years, FDA)
- 849 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (17)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253703 | 2026-07-24 | Deka R&D Corp | RemunityPRO+ Pump for Remodulin® (treprostinil) Inje… | |
| K252015 | 2026-01-28 | Koru Medical Systems, Inc. | FreedomEdge Infusion System; High-Flo SubQ Needle Se… | |
| K251640 | 2025-07-28 | Baxter Healthcare Corporation | SIGMA Spectrum Infusion Pump with Master Drug Librar… | |
| K251636 | 2025-07-28 | Baxter Healthcare Corporation | Spectrum IQ Infusion System with Dose IQ Safety Soft… | |
| K242752 | 2025-05-28 | Iradimed Corporation | MRidium 3870 MRI Infusion Pump System (3870) | |
| K243855 | 2025-04-25 | Carefusion 303, Inc. | BD Alaris Infusion System with Guardrails Suite MX | |
| K242115 | 2025-04-02 | Icu Medical, Inc. | Plum Duo Precision IV Pump | |
| K242114 | 2025-04-02 | Icu Medical, Inc. | Plum Solo Precision IV Pump | |
| K250357 | 2025-03-11 | Deka Research & Development Corp. | RemunityPRO Pump for Remodulin® (treprostinil) Inje… | |
| K241736 | 2025-01-16 | Deka Research and Development Corp. | Remunity 2.0 Pump for Remodulin (treprostinil) Injec… | |
| K242735 | 2024-12-23 | Belmont Medical Technologies | Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 100… | |
| K242660 | 2024-10-03 | Zevex, Inc. | Curlin 8000 Ambulatory Infusion System; Enterprise S… | FDA |
| K242390 | 2024-09-05 | Baxter Healthcare Corporation | Novum IQ Syringe Pump (40800BAXUS) | |
| K232793 | 2024-05-17 | Zevex, Inc. | Curlin 8000 Ambulatory Infusion System; Enterprise S… | |
| K211122 | 2024-03-29 | Baxter Healthcare Corporation | Novum IQ Large Volume Pump | |
| K231918 | 2023-11-03 | Koru Medical Systems | Freedom60 Infusion Pump; High-Flo Subcutaneous Needl… | |
| K230083 | 2023-10-31 | Medovate Limited | SAFIRA |
Official FDA classification page: FRN
Classification and pathway per current FDA publications. Data from openFDA (CC0).