safety lancet
FDA 510(k) K251694 · Tianjin Huahong Technology Co., Ltd.
Submission
- Device name
- safety lancet
- Applicant
- Tianjin Huahong Technology Co., Ltd.
Tianjin, CN - Received
- June 2, 2025
- Decision date
- June 26, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| K244036 | Heel Incision Safety Lancet (SteriHeel 2)FMK · Traditional | SteriLance Medical (Suzhou), Inc. | 02/26/2025SE |
| 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 |
|---|---|---|
| K262526 | Safety lancet (XL)FMK · Traditional | 09/13/2026SE |
| K262135 | Lancing deviceQRL · Traditional | 08/18/2026SE |
| K260845 | Huahong Sharps Container (HHR-I, HHR-II)MMK · Traditional | 08/05/2026SE |
| K262211 | LancetQRL · Special | 07/22/2026SE |
| K260191 | Safety lancet (XXXVII)FMK · Traditional | 03/31/2026SE |
| K252490 | Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)FMK · Special | 02/12/2026SE |
| K253706 | Lancing device (HH-XV-T)QRL · Special | 12/09/2025SE |
| K243306 | Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing…QRL · Special | 11/15/2024SE |
| K241627 | Safety Lancet (XXXV)FMK · Traditional | 06/20/2024SE |
| K240806 | Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.)FMK · Traditional | 05/21/2024SE |
Questions and answers
When was safety lancet cleared by the FDA?
safety lancet (K251694) received a 510(k) decision of Substantially Equivalent on June 26, 2025, 24 days after the submission was received.
What is the product code of K251694?
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.