QRL — Multiple Use Blood Lancet For Single Patient Use Only Class II
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 |
|---|---|---|---|
| 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 |
| K220387 | suzhou kyuan medical apparatus co | Disposable Blood Lancets | August 17, 2022 |