QRK — Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature Class II
Classification Details
- Product Code
- QRK
- Device Class
- Class II
- Regulation Number
- 878.4850
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, nonreusable 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 |
|---|---|---|---|
| K250016 | htl-strefa | droplet® personal lancets | July 1, 2025 |
| K244031 | sterilance medical (suzhou) | Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposab | February 26, 2025 |
| K242622 | ningbo caremed medical products co | Sterile Lancets for Single Use | October 28, 2024 |
| K241810 | ascensia diabetes care u.s | MICROLET®NEXT Lancet | August 15, 2024 |
| K232330 | ningbo medsun medical co | Lancing System | January 4, 2024 |
| K230712 | sewon medical | SG Lanset I, SG Lancets, Soft Lancets | December 6, 2023 |
| K230310 | stat medical devices | STAT Medical Device Lancing System | September 8, 2023 |
| K230759 | bosungmeditech co | SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro | June 13, 2023 |
| K222617 | stat medical devices | EasyTouch Lancing Device | March 21, 2023 |
| K223815 | stat medical devices | ONE DROP Lancing Device | February 15, 2023 |
| K223314 | huaian hening medical instruments co | Disposable Blood Lancets | January 25, 2023 |
| K223480 | medipoint holdings | Medipoint Blood Lancets | January 13, 2023 |
| K221383 | shanghai carelife international trading co. | MedtFine Blood Lancet | September 21, 2022 |
| K221507 | sterilance medical (suzhou) | Disposable Blood Lancet | August 31, 2022 |
| K221433 | facet technologies | Facet 28G Universal Lancet | July 15, 2022 |