QRK — Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature Class II
FDA product code QRK covers "Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature", a Class II medical device regulated under 21 CFR 878.4850. Submissions are reviewed by the General, Plastic Surgery panel. At least 16 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K261634 | sterilance medical (suzhou) | Disposable Blood Lancet (Soft) | June 12, 2026 |
| 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 |