Heel Incision Safety Lancet (SteriHeel 2)
FDA 510(k) K244036 · SteriLance Medical (Suzhou), Inc.
Submission
- Device name
- Heel Incision Safety Lancet (SteriHeel 2)
- Applicant
- SteriLance Medical (Suzhou), Inc.
Suzhou, CN - Received
- December 30, 2024
- Decision date
- February 26, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMK – Single Use Only Blood Lancet With 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, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable…
Other 510(k)s with product code FMK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262526 | Safety lancet (XL)FMK · Traditional | Tianjin Huahong Technology Co., Ltd. | 09/13/2026SE |
| K261045 | Verifine Safety LancetsFMK · Special | Promisemed Hangzhou Meditech Co., Ltd. | 05/01/2026SE |
| K260191 | Safety lancet (XXXVII)FMK · Traditional | Tianjin Huahong Technology Co., Ltd. | 03/31/2026SE |
| K253605 | Safety Heel LancetFMK · Traditional | Ningbo Medsun Medical Co., Ltd. | 02/20/2026SE |
| K252490 | Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)FMK · Special | Tianjin Huahong Technology Co., Ltd. | 02/12/2026SE |
| K251694 | safety lancetFMK · Special | Tianjin Huahong Technology Co., Ltd. | 06/26/2025SE |
| K243533 | Sterilized Eol Auto Lancet; Sterilized Eol Lancet PlusFMK · Traditional | Hlb Co., Ltd. Healthcare | 01/13/2025SE |
| K242680 | LetsGetChecked ImpressFMK · Traditional | Privapath Diagnostics Ltd (Dba Letsgetchecked) | 01/13/2025SESU |
| K242664 | gentleheel® Adult Incision DeviceFMK · Traditional | Gri-Alleset, Inc. | 11/05/2024SE |
| K242627 | Safety LancetFMK · Traditional | Ningbo Medsun Medical Co., Ltd. | 10/30/2024SE |
More from Ningbo Medsun Medical Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K262631 | Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)QRK · Special | 08/25/2026SE |
| K260122 | Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)QRL · Traditional | 07/06/2026SE |
| K261634 | Disposable Blood Lancet (Soft)QRK · Special | 06/12/2026SE |
| K244031 | Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood…QRK · Traditional | 02/26/2025SE |
| K233796 | Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable…FMK · Traditional | 01/16/2024SE |
| K221521 | Disposable Safety LancetFMK · Traditional | 10/28/2022SE |
| K221507 | Disposable Blood LancetQRK · Traditional | 08/31/2022SE |
| K221970 | Lancing deviceQRL · Traditional | 08/30/2022SE |
| K210745 | Heel Incision Safety LancetFMK · Traditional | 08/26/2021SE |
| K153706 | Insulin Pen NeedleFMI · Traditional | 08/29/2016SE |
Questions and answers
When was Heel Incision Safety Lancet (SteriHeel 2) cleared by the FDA?
Heel Incision Safety Lancet (SteriHeel 2) (K244036) received a 510(k) decision of Substantially Equivalent on February 26, 2025, 58 days after the submission was received.
What is the product code of K244036?
The FDA product code is FMK – Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature, a Class II (moderate risk) device regulated under 21 CFR 878.4850.