QRL
- Product code
- QRL
- Device name
- Multiple Use Blood Lancet For Single Patient Use Only
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.4850
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 27
FDA classification definition
A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.
510(k) clearances, last 3 years (8)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K262135 | 2026-08-18 | Tianjin Huahong Technology Co., Ltd. | Lancing device | |
| K262211 | 2026-07-22 | Tianjin Huahong Technology Co., Ltd. | Lancet | |
| K260122 | 2026-07-06 | SteriLance Medical (Suzhou), Inc. | Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasySt | |
| K253706 | 2025-12-09 | Tianjin Huahong Technology Co., Ltd. | Lancing device (HH-XV-T) | |
| K250813 | 2025-05-14 | Ascensia Diabetes Care U.S., Inc. | MICROLET®NEXT 2 Lancing Device | |
| K243306 | 2024-11-15 | Tianjin Huahong Technology Co., Ltd. | Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, II | |
| K232912 | 2024-01-25 | Facet Technologies, LLC | Facet Aurora Reusable Lancet Base | |
| K231797 | 2023-11-22 | Medifun Corporation | Medifun Lancing Device, Model No. LD-E1 |
Official FDA classification page: QRL
Classification and pathway per current FDA publications. Data from openFDA (CC0).