QRK
- Product code
- QRK
- Device name
- Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
- 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)
- 17
FDA classification 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.
510(k) clearances, last 3 years (8)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K262631 | 2026-08-25 | SteriLance Medical (Suzhou), Inc. | Disposable blood lancet (Soft Pro, Softsure, Softsur | |
| K261634 | 2026-06-12 | SteriLance Medical (Suzhou), Inc. | Disposable Blood Lancet (Soft) | |
| K250016 | 2025-07-01 | Htl-Strefa S.A | droplet® personal lancets | |
| K244031 | 2025-02-26 | SteriLance Medical (Suzhou), Inc. | Disposable Blood Lancet (Soft Pro); Disposable Blood | |
| K242622 | 2024-10-28 | Ningbo Caremed Medical Products Co., L | Sterile Lancets for Single Use | |
| K241810 | 2024-08-15 | Ascensia Diabetes Care U.S., Inc. | MICROLET®NEXT Lancet | |
| K232330 | 2024-01-04 | Ningbo Medsun Medical Co., Ltd. | Lancing System | |
| K230712 | 2023-12-06 | Sewon Medical Co. | SG Lanset I, SG Lancets, Soft Lancets |
Official FDA classification page: QRK
Classification and pathway per current FDA publications. Data from openFDA (CC0).