FMI
- 产品代码
- FMI
- 器械名称
- Needle, Hypodermic, Single Lumen
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 880.5570
- FDA 专业组
- General Hospital
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
- 该代码近三年的 510(k)
- 693 件
该代码近三年的 510(k)（30 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K261719 | 2026-08-25 | Promisemed Hangzhou Meditech Co., Ltd. | Promisemed X-Safety Pen Needle 摘要 |
| K262427 | 2026-08-10 | Hh Global Technology, Inc. | Pen Needle (Ordinary Type I, Safety Type IIA, Safety 摘要 |
| K260933 | 2026-08-07 | Hangzhou Qiantang Longyue Biotechnolog | Safety Sterile Hypodermic Needles (NR-S1816R, NR-S19 摘要 |
| K261829 | 2026-07-29 | CMT Health PTE., Ltd. | Profoject Dual-Safety Pen Needles 摘要 |
| K260739 | 2026-07-15 | CMT Health PTE., Ltd. | Profoject Pen Needles (Model A; Model B) 摘要 |
| K260855 | 2026-06-10 | CMT Health PTE., Ltd. | Profoject Safety Pen Needles 摘要 |
| K254273 | 2026-04-16 | Promisemed Hangzhou Meditech Co., Ltd. | Verisafe Safety Sterile Needles (SSN) |
| K252908 | 2026-03-25 | Sandstone Medical (Suzhou), Inc. | Easydrip Classic Pen Needle; Easydrip Plus Pen Needl 摘要 |
| K253047 | 2026-03-24 | Nipro Medical Corporation | PRESSONE 摘要 |
| K253622 | 2026-03-18 | Ningbo Medsun Medical Co., Ltd. | Safety Pen Needle 摘要 |
| K252886 | 2026-01-06 | Hh Global Technology, Inc. | Pen Needle 摘要 |
| K250700 | 2025-11-21 | Terumo Corporation | Pen Injector Needle 32.5 摘要 |
| K252631 | 2025-10-16 | CMT Health PTE., Ltd. | Profoject Disposable Needle 摘要 |
| K250724 | 2025-07-30 | Spectrum Vascular | Intraosseous Infusion Needles 摘要 |
| K250284 | 2025-07-24 | Tsk Laboratory, Japan | TSK SELECT Needle 摘要 |
| K251447 | 2025-07-08 | Terumo Europe N.V. | K-Pack Embrace Active Safety Needle (KNAS-2516RB, KN 摘要 |
| K243309 | 2025-05-29 | Terumo Europe N.V. | 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) 摘要 |
| K240355 | 2025-04-18 | Carrtech Corp | FROG (Filter Removal of Glass) 摘要 |
| K243581 | 2025-04-04 | Terumo Europe N.V. | K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC 摘要 |
| K250658 | 2025-04-03 | Shina Med Corporation | SureFine Pen Needle 摘要 |
| K243806 | 2025-01-10 | Promisemed Hangzhou Meditech Co., Ltd. | Safety Winged Blood Collection Sets 摘要 |
| K242741 | 2025-01-08 | Ace Medical Industry Co., Ltd. | ACE Cannula 摘要 |
| K242632 | 2024-09-26 | Promisemed Hangzhou Meditech Co., Ltd. | Verifine® Pen Needles 摘要 |
| K240915 | 2024-07-02 | Zien Medical Technologies, Inc. | ZIEN IO Intraosseous Access System 摘要 |
| K232165 | 2024-02-01 | Berpu Medical Technology Co., Ltd. | Sterile Safety Hypodermic Needles for Single Use; St 摘要 |
| K233037 | 2023-12-12 | Zhejiang Kindly Medical Device Co., Lt | Sterile Hypodermic Needles for Single Use 摘要 |
| K233343 | 2023-11-27 | Ocuject, LLC | SteriCap Safety Needle; VitreJect Safety Needle 摘要 |
| K230070 | 2023-10-05 | Promamedical, Inc. | MESORAM® Hypodermic Needle (710301); MESORAM® Hypode 摘要 |
| K230043 | 2023-09-20 | Anhui Hongyu Wuzhou Medical Manufactur | Insulin Pen Needle 摘要 |
| K230959 | 2023-09-14 | Ocuject, LLC | VitreJect® Needle; OcuSafe® Needle 摘要 |
FDA 官方分类页： FMI
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。