QRL — Multiple Use Blood Lancet For Single Patient Use Only Class II
FDA product code QRL covers "Multiple Use Blood Lancet For Single Patient Use Only", a Class II medical device regulated under 21 CFR 878.4850. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QRL
- Device Class
- Class II
- Regulation Number
- 878.4850
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260122 | sterilance medical (suzhou) | Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep) | July 6, 2026 |
| K253706 | tianjin huahong technology co | Lancing device (HH-XV-T) | December 9, 2025 |
| K250813 | ascensia diabetes care u.s | MICROLET®NEXT 2 Lancing Device | May 14, 2025 |
| K243306 | tianjin huahong technology co | Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); La | November 15, 2024 |
| K232912 | facet technologies | Facet Aurora Reusable Lancet Base | January 25, 2024 |
| K231797 | medifun corporation | Medifun Lancing Device, Model No. LD-E1 | November 22, 2023 |
| K223643 | promisemed hangzhou meditech co | Verifine® Ease Lancing Device, Verifine® Lancing Device | February 21, 2023 |
| K221419 | gostar co | TD-5010 Lancing Device and TD-5084 Sterile Lancets | January 20, 2023 |
| K222472 | shandong lianfa medical plastic products co. | Lancing System, Sterile Lancet for Single Use, Lancing Device | November 30, 2022 |
| K223099 | facet technologies | Facet Manatee Reusable Lancing Base | November 28, 2022 |
| K222656 | i-sens | LDE4 Lancing Device | November 23, 2022 |
| K222246 | tianjin rilifine medical device co | Disposable Sterile Lancet | November 21, 2022 |
| K222539 | facet technologies | Facet Blood Lancets | November 18, 2022 |
| K221072 | trividia health | TRUEdraw Lancing Device, Mini Lancing Device | October 18, 2022 |
| K221175 | arkray | Multi-Lancet Device 2, ReliOn Premier Lancing Device | October 17, 2022 |
| K221613 | owen mumford | Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets | October 3, 2022 |
| K221062 | bionime corporation | RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device | September 26, 2022 |
| K222034 | beijing ruicheng medical supplies co | RightLance Blood Lancing System | September 7, 2022 |
| K221970 | sterilance medical (suzhou) | Lancing device | August 30, 2022 |
| K221546 | asahi polyslider co | OneTouch Delica Plus Lancing System | August 23, 2022 |