FDA 510(k) Applications for Medical Device Product Code "QRK"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K241810 | Ascensia Diabetes Care US Inc | MICROLET«NEXT Lancet | 08/15/2024 |
| K230759 | Bosungmeditech Co., Ltd. | SafeLan« (2 models/SafeLan 26G, SafeLan 30G), SafeLan«-Pro (1 model/SafeLan«-Pro) | 06/13/2023 |
| K221433 | Facet Technologies LLC | Facet 28G Universal Lancet | 07/15/2022 |
| K250016 | HTL-Strefa S.A. | droplet« personal lancets | 07/01/2025 |
| K223314 | HUAIAN HENING MEDICAL INSTRUMENTS CO., LTD | Disposable Blood Lancets | 01/25/2023 |
| K223480 | Medipoint Holdings, LLC | Medipoint Blood Lancets | 01/13/2023 |
| K242622 | Ningbo Caremed Medical Products Co., Ltd. | Sterile Lancets for Single Use | 10/28/2024 |
| K232330 | Ningbo Medsun Medical Co., Ltd. | Lancing System | 01/04/2024 |
| K230712 | Sewon Medical Co. | SG Lanset I, SG Lancets, Soft Lancets | 12/06/2023 |
| K221383 | Shanghai Carelife International Trading Co. Ltd. | MedtFine Blood Lancet | 09/21/2022 |
| K222617 | STAT Medical Devices | EasyTouch Lancing Device | 03/21/2023 |
| K223815 | STAT Medical Devices | ONE DROP Lancing Device | 02/15/2023 |
| K230310 | STAT Medical Devices | STAT Medical Device Lancing System | 09/08/2023 |
| K221507 | SteriLance Medical (Suzhou) Inc. | Disposable Blood Lancet | 08/31/2022 |
| K244031 | SteriLance Medical (Suzhou) Inc. | Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense) | 02/26/2025 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
