Lancing device (HH-XV-T)
FDA 510(k) K253706 · Tianjin Huahong Technology Co., Ltd.
510(k) numberK253706
Submission
- Device name
- Lancing device (HH-XV-T)
- Applicant
- Tianjin Huahong Technology Co., Ltd.
Tianjin, CN - Received
- November 24, 2025
- Decision date
- December 9, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QRL – Multiple Use Blood Lancet For Single Patient Use Only
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4850
- Specialty
- General, Plastic Surgery
A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.
Other 510(k)s with product code QRL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262135 | Lancing deviceQRL · Traditional | Tianjin Huahong Technology Co., Ltd. | 08/18/2026SE |
| K262211 | LancetQRL · Special | Tianjin Huahong Technology Co., Ltd. | 07/22/2026SE |
| K260122 | Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)QRL · Traditional | SteriLance Medical (Suzhou), Inc. | 07/06/2026SE |
| K250813 | MICROLET®NEXT 2 Lancing DeviceQRL · Traditional | Ascensia Diabetes Care U.S., Inc. | 05/14/2025SE |
| K243306 | Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing…QRL · Special | Tianjin Huahong Technology Co., Ltd. | 11/15/2024SE |
| K232912 | Facet Aurora Reusable Lancet BaseQRL · Traditional | Facet Technologies, LLC | 01/25/2024SE |
| K231797 | Medifun Lancing Device, Model No. LD-E1QRL · Traditional | Medifun Corporation | 11/22/2023SE |
| K223643 | Verifine® Ease Lancing Device, Verifine® Lancing DeviceQRL · Traditional | Promisemed Hangzhou Meditech Co., Ltd. | 02/21/2023SE |
| K221419 | TD-5010 Lancing Device and TD-5084 Sterile LancetsQRL · Traditional | Gostar Co., Ltd. | 01/20/2023SE |
| K222472 | Lancing System, Sterile Lancet for Single Use, Lancing DeviceQRL · Traditional | Shandong Lianfa Medical Plastic Products Co.… | 11/30/2022SE |
More from Shandong Lianfa Medical Plastic Products 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 |
| K251694 | safety lancetFMK · Special | 06/26/2025SE |
| 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 Lancing device (HH-XV-T) cleared by the FDA?
Lancing device (HH-XV-T) (K253706) received a 510(k) decision of Substantially Equivalent on December 9, 2025, 15 days after the submission was received.
What is the product code of K253706?
The FDA product code is QRL – Multiple Use Blood Lancet For Single Patient Use Only, a Class II (moderate risk) device regulated under 21 CFR 878.4850.