Safety lancet (XL)— 510(k) K262526
Substantially EquivalentTianjin Huahong Technology Co., Ltd.
FDA 510(k) clearance K262526 for Safety lancet (XL), Substantially Equivalent on 2026-09-13. Applicant: Tianjin Huahong Technology Co., Ltd.. Device class: 2.
Summary
A single-use blood lancet with a built-in sharps injury prevention feature, which is exactly what product code FMK covers. The code's definition describes a single-use blade on a non-reusable base that punctures the skin to get a drop of blood for diagnostic purposes, with a safety feature that makes it inoperable after one use. The record doesn't explain the "XL."
Class II, 21 CFR 878.4850. The General and Plastic Surgery panel reviewed it as a Traditional 510(k).
Tianjin Huahong Technology filed from Tianjin, China, and had a decision in 53 days (July 22 to September 13, 2026).
Clearance details
- Applicant
- Tianjin Huahong Technology Co., Ltd.
- Product code
- Product code FMK
- Device class
- Class 2
- Regulation
- 21 CFR 878.4850
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tianjin, CN
Recent devices under product code FMK
view allMore clearances from Tianjin Huahong Technology Co., Ltd.
view allAdverse events under product code FMK
product code FMK- Injury
- 133
- Malfunction
- 1,278
- Other
- 1
- Total
- 1,412
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.