Panels › General, Plastic Surgery › Product code QRK · Class 2
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
Regulation 878.4850
2510(k)s in 12 months (17 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QRK
| Company | 510(k)s | Recalls |
|---|---|---|
| SteriLance Medical (Suzhou), Inc. | 4 | 0 |
| Stat Medical Devices | 3 | 0 |
| Ascensia Diabetes Care U.S., Inc. | 1 | 0 |
| Bosungmeditech Co., Ltd. | 1 | 0 |
| Facet Technologies, LLC | 1 | 0 |
| Htl-Strefa S.A | 1 | 0 |
| Huaian Hening Medical Instruments Co., Ltd. | 1 | 0 |
| Medipoint Holdings, LLC | 1 | 0 |
| Ningbo Caremed Medical Products Co., Ltd. | 1 | 0 |
| Ningbo Medsun Medical Co., Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 25, 2026 | K262631 | Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense) SteriLance Medical (Suzhou), Inc., CN | QRK |
| Jun 12, 2026 | K261634 | Disposable Blood Lancet (Soft) SteriLance Medical (Suzhou), Inc., CN | QRK |
| Jul 1, 2025 | K250016 | droplet® personal lancets Htl-Strefa S.A, PL | QRK |
| Feb 26, 2025 | K244031 | Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposab SteriLance Medical (Suzhou), Inc., CN | QRK |
| Oct 28, 2024 | K242622 | Sterile Lancets for Single Use Ningbo Caremed Medical Products Co., Ltd., CN | QRK |
| Aug 15, 2024 | K241810 | MICROLET®NEXT Lancet Ascensia Diabetes Care U.S., Inc. | QRK |
| Jan 4, 2024 | K232330 | Lancing System Ningbo Medsun Medical Co., Ltd., CN | QRK |
| Dec 6, 2023 | K230712 | SG Lanset I, SG Lancets, Soft Lancets Sewon Medical Co., KR | QRK |
| Sep 8, 2023 | K230310 | STAT Medical Device Lancing System Stat Medical Devices | QRK |
| Jun 13, 2023 | K230759 | SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro) Bosungmeditech Co., Ltd., KR | QRK |
| Mar 21, 2023 | K222617 | EasyTouch Lancing Device Stat Medical Devices | QRK |
| Feb 15, 2023 | K223815 | ONE DROP Lancing Device Stat Medical Devices | QRK |
| Jan 25, 2023 | K223314 | Disposable Blood Lancets Huaian Hening Medical Instruments Co., Ltd., CN | QRK |
| Jan 13, 2023 | K223480 | Medipoint Blood Lancets Medipoint Holdings, LLC | QRK |
| Sep 21, 2022 | K221383 | MedtFine Blood Lancet Shanghai Carelife International Trading Co. , Ltd., CN | QRK |
| Aug 31, 2022 | K221507 | Disposable Blood Lancet SteriLance Medical (Suzhou), Inc., CN | QRK |
| Jul 15, 2022 | K221433 | Facet 28G Universal Lancet Facet Technologies, LLC | QRK |
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