SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro)
FDA 510(k) K230759 · Bosungmeditech Co., Ltd.
510(k) numberK230759
Submission
- Device name
- SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro)
- Applicant
- Bosungmeditech Co., Ltd.
Wonju, KR - Received
- March 20, 2023
- Decision date
- June 13, 2023
- 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 |
| K244031 | Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood…QRK · Traditional | SteriLance Medical (Suzhou), Inc. | 02/26/2025SE |
| 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 |
| K222617 | EasyTouch Lancing DeviceQRK · Traditional | Stat Medical Devices | 03/21/2023SE |
Questions and answers
When was SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro) cleared by the FDA?
SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro) (K230759) received a 510(k) decision of Substantially Equivalent on June 13, 2023, 85 days after the submission was received.
What is the product code of K230759?
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.