FMK
- 产品代码
- FMK
- 器械名称
- Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 878.4850
- FDA 专业组
- General, Plastic Surgery
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 110 件
FDA 分类定义
A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use.
该代码近三年的 510(k)（20 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K261045 | 2026-05-01 | Promisemed Hangzhou Meditech Co., Ltd. | Verifine Safety Lancets 摘要 |
| K260191 | 2026-03-31 | Tianjin Huahong Technology Co., Ltd. | Safety lancet (XXXVII) 摘要 |
| K253605 | 2026-02-20 | Ningbo Medsun Medical Co., Ltd. | Safety Heel Lancet 摘要 |
| K252490 | 2026-02-12 | Tianjin Huahong Technology Co., Ltd. | Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV) 摘要 |
| K251694 | 2025-06-26 | Tianjin Huahong Technology Co., Ltd. | safety lancet 摘要 |
| K244036 | 2025-02-26 | SteriLance Medical (Suzhou), Inc. | Heel Incision Safety Lancet (SteriHeel 2) 摘要 |
| K242680 | 2025-01-13 | Privapath Diagnostics Ltd (Dba Letsget | LetsGetChecked Impress 摘要 |
| K243533 | 2025-01-13 | Hlb Co., Ltd. Healthcare | Sterilized Eol Auto Lancet; Sterilized Eol Lancet Pl 摘要 |
| K242664 | 2024-11-05 | Gri-Alleset, Inc. | gentleheel® Adult Incision Device 摘要 |
| K242627 | 2024-10-30 | Ningbo Medsun Medical Co., Ltd. | Safety Lancet 摘要 |
| K242316 | 2024-08-28 | Ningbo Medsun Medical Co., Ltd. | Safety Lancet 摘要 |
| K241848 | 2024-08-20 | Ningbo Caremed Medical Products Co., L | MedtFine Safety Lancet 摘要 |
| K241750 | 2024-08-15 | Medifun Corporation | Medifun Safety Lancet ( MSL1 series) 摘要 |
| K241627 | 2024-06-20 | Tianjin Huahong Technology Co., Ltd. | Safety Lancet (XXXV) 摘要 |
| K240806 | 2024-05-21 | Tianjin Huahong Technology Co., Ltd. | Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXII 摘要 |
| K234081 | 2024-03-21 | Reddrop DX | RedDrop ONE (One) 摘要 |
| K223826 | 2024-02-22 | Drawbridge Health, Inc. | NanoDrop Lancet 摘要 |
| K233796 | 2024-01-16 | SteriLance Medical (Suzhou), Inc. | Disposable safety lancet (Impress); Disposable safet 摘要 |
| K232509 | 2023-11-13 | Roche Diabetes Care, Inc. | Accu-Chek Safe-T-Pro Uno Lancing Device 摘要 |
| K232488 | 2023-11-13 | Roche Diabetes Care, Inc. | Accu-Chek Safe-T-Pro Plus Lancing Device 摘要 |
FDA 官方分类页： FMK
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。