FDA Product Code
FDA Product Code QRK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4850
510(k) Clearances — 17 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262631 | Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense) | SteriLance Medical (Suzhou), Inc. | 2026-08-25 | Special | PDF ↗ |
| K261634 | Disposable Blood Lancet (Soft) | SteriLance Medical (Suzhou), Inc. | 2026-06-12 | Special | PDF ↗ |
| K250016 | droplet® personal lancets | Htl-Strefa S.A | 2025-07-01 | Traditional | PDF ↗ |
| K244031 | Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense) | SteriLance Medical (Suzhou), Inc. | 2025-02-26 | Traditional | PDF ↗ |
| K242622 | Sterile Lancets for Single Use | Ningbo Caremed Medical Products Co., Ltd. | 2024-10-28 | Traditional | PDF ↗ |
| K241810 | MICROLET®NEXT Lancet | Ascensia Diabetes Care U.S., Inc. | 2024-08-15 | Traditional | PDF ↗ |
| K232330 | Lancing System | Ningbo Medsun Medical Co., Ltd. | 2024-01-04 | Traditional | PDF ↗ |
| K230712 | SG Lanset I, SG Lancets, Soft Lancets | Sewon Medical Co. | 2023-12-06 | Traditional | PDF ↗ |
| K230310 | STAT Medical Device Lancing System | Stat Medical Devices | 2023-09-08 | Traditional | PDF ↗ |
| K230759 | SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro) | Bosungmeditech Co., Ltd. | 2023-06-13 | Traditional | PDF ↗ |
| K222617 | EasyTouch Lancing Device | Stat Medical Devices | 2023-03-21 | Traditional | PDF ↗ |
| K223815 | ONE DROP Lancing Device | Stat Medical Devices | 2023-02-15 | Traditional | PDF ↗ |
| K223314 | Disposable Blood Lancets | Huaian Hening Medical Instruments Co., Ltd. | 2023-01-25 | Traditional | PDF ↗ |
| K223480 | Medipoint Blood Lancets | Medipoint Holdings, LLC | 2023-01-13 | Traditional | PDF ↗ |
| K221383 | MedtFine Blood Lancet | Shanghai Carelife International Trading Co. , Ltd. | 2022-09-21 | Traditional | PDF ↗ |
| K221507 | Disposable Blood Lancet | SteriLance Medical (Suzhou), Inc. | 2022-08-31 | Traditional | PDF ↗ |
| K221433 | Facet 28G Universal Lancet | Facet Technologies, LLC | 2022-07-15 | Traditional | PDF ↗ |
Product code QRK · Class II · General, Plastic Surgery. Data: openFDA.