FRN
- 产品代码
- FRN
- 器械名称
- Pump, Infusion
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 880.5725
- FDA 专业组
- General Hospital
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 849 件
该代码近三年的 510(k)（17 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K253703 | 2026-07-24 | Deka R&D Corp | RemunityPRO+ Pump for Remodulin® (treprostinil) Inje 摘要 |
| K252015 | 2026-01-28 | Koru Medical Systems, Inc. | FreedomEdge Infusion System; High-Flo SubQ Needle Se 摘要 |
| K251640 | 2025-07-28 | Baxter Healthcare Corporation | SIGMA Spectrum Infusion Pump with Master Drug Librar 摘要 |
| K251636 | 2025-07-28 | Baxter Healthcare Corporation | Spectrum IQ Infusion System with Dose IQ Safety Soft 摘要 |
| K242752 | 2025-05-28 | Iradimed Corporation | MRidium 3870 MRI Infusion Pump System (3870) 摘要 |
| K243855 | 2025-04-25 | Carefusion 303, Inc. | BD Alaris Infusion System with Guardrails Suite MX 摘要 |
| K242115 | 2025-04-02 | Icu Medical, Inc. | Plum Duo Precision IV Pump 摘要 |
| K242114 | 2025-04-02 | Icu Medical, Inc. | Plum Solo Precision IV Pump 摘要 |
| K250357 | 2025-03-11 | Deka Research & Development Corp. | RemunityPRO Pump for Remodulin® (treprostinil) Inje 摘要 |
| K241736 | 2025-01-16 | Deka Research and Development Corp. | Remunity 2.0 Pump for Remodulin (treprostinil) Injec 摘要 |
| K242735 | 2024-12-23 | Belmont Medical Technologies | Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 100 摘要 |
| K242660 | 2024-10-03 | Zevex, Inc. | Curlin 8000 Ambulatory Infusion System; Enterprise S 摘要 |
| K242390 | 2024-09-05 | Baxter Healthcare Corporation | Novum IQ Syringe Pump (40800BAXUS) 摘要 |
| K232793 | 2024-05-17 | Zevex, Inc. | Curlin 8000 Ambulatory Infusion System; Enterprise S 摘要 |
| K211122 | 2024-03-29 | Baxter Healthcare Corporation | Novum IQ Large Volume Pump 摘要 |
| K231918 | 2023-11-03 | Koru Medical Systems | Freedom60 Infusion Pump; High-Flo Subcutaneous Needl 摘要 |
| K230083 | 2023-10-31 | Medovate Limited | SAFIRA 摘要 |
FDA 官方分类页： FRN
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。