Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense)
FDA 510(k) K244031 · SteriLance Medical (Suzhou), Inc.
510(k) numberK244031
Submission
- Device name
- Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense)
- Applicant
- SteriLance Medical (Suzhou), Inc.
Suzhou, CN - Received
- December 30, 2024
- Decision date
- February 26, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QRK – Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4850
- Specialty
- General, Plastic Surgery
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.
Other 510(k)s with product code QRK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262631 | Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)QRK · Special | SteriLance Medical (Suzhou), Inc. | 08/25/2026SE |
| K261634 | Disposable Blood Lancet (Soft)QRK · Special | SteriLance Medical (Suzhou), Inc. | 06/12/2026SE |
| K250016 | droplet® personal lancetsQRK · Traditional | Htl-Strefa S.A | 07/01/2025SE |
| K242622 | Sterile Lancets for Single UseQRK · Traditional | Ningbo Caremed Medical Products Co., Ltd. | 10/28/2024SE |
| K241810 | MICROLET®NEXT LancetQRK · Traditional | Ascensia Diabetes Care U.S., Inc. | 08/15/2024SE |
| K232330 | Lancing SystemQRK · Traditional | Ningbo Medsun Medical Co., Ltd. | 01/04/2024SE |
| K230712 | SG Lanset I, SG Lancets, Soft LancetsQRK · Traditional | Sewon Medical Co. | 12/06/2023SE |
| K230310 | STAT Medical Device Lancing SystemQRK · Traditional | Stat Medical Devices | 09/08/2023SE |
| K230759 | SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro)QRK · Traditional | Bosungmeditech Co., Ltd. | 06/13/2023SE |
| K222617 | EasyTouch Lancing DeviceQRK · Traditional | Stat Medical Devices | 03/21/2023SE |
More from Stat Medical Devices
| 510(k) | Device | Decision |
|---|---|---|
| K262631 | Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)QRK · Special | 08/25/2026SE |
| K260122 | Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)QRL · Traditional | 07/06/2026SE |
| K261634 | Disposable Blood Lancet (Soft)QRK · Special | 06/12/2026SE |
| K244036 | Heel Incision Safety Lancet (SteriHeel 2)FMK · Traditional | 02/26/2025SE |
| K233796 | Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable…FMK · Traditional | 01/16/2024SE |
| K221521 | Disposable Safety LancetFMK · Traditional | 10/28/2022SE |
| K221507 | Disposable Blood LancetQRK · Traditional | 08/31/2022SE |
| K221970 | Lancing deviceQRL · Traditional | 08/30/2022SE |
| K210745 | Heel Incision Safety LancetFMK · Traditional | 08/26/2021SE |
| K153706 | Insulin Pen NeedleFMI · Traditional | 08/29/2016SE |
Questions and answers
When was Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense) cleared by the FDA?
Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense) (K244031) received a 510(k) decision of Substantially Equivalent on February 26, 2025, 58 days after the submission was received.
What is the product code of K244031?
The FDA product code is QRK – Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature, a Class II (moderate risk) device regulated under 21 CFR 878.4850.