Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense)
FDA 510(k) clearance K244031 · decided 2025-02-26
Clearance details
- K-number
- K244031
- 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.
- Decision
- Substantially Equivalent
- Date received
- 2024-12-30
- Decision date
- 2025-02-26
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- QRK
- Device class
- 2
- Regulation number
- 878.4850
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Suzhou, CN
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Disposable Blood Lancet (Soft) (K261634) | SteriLance Medical (Suzhou), Inc. | 2026-06-12 |
| droplet® personal lancets (K250016) | Htl-Strefa S.A | 2025-07-01 |
| Sterile Lancets for Single Use (K242622) | Ningbo Caremed Medical Products Co., Ltd. | 2024-10-28 |
| MICROLET®NEXT Lancet (K241810) | Ascensia Diabetes Care U.S., Inc. | 2024-08-15 |
| Lancing System (K232330) | Ningbo Medsun Medical Co., Ltd. | 2024-01-04 |
| SG Lanset I, SG Lancets, Soft Lancets (K230712) | Sewon Medical Co. | 2023-12-06 |
| STAT Medical Device Lancing System (K230310) | Stat Medical Devices | 2023-09-08 |
| SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro) (K230759) | Bosungmeditech Co., Ltd. | 2023-06-13 |
| EasyTouch Lancing Device (K222617) | Stat Medical Devices | 2023-03-21 |
| ONE DROP Lancing Device (K223815) | Stat Medical Devices | 2023-02-15 |
| Disposable Blood Lancets (K223314) | Huaian Hening Medical Instruments Co., Ltd. | 2023-01-25 |
| Medipoint Blood Lancets (K223480) | Medipoint Holdings, LLC | 2023-01-13 |
Recalls involving this device
No recalls on record reference this clearance.