Safety lancet (XXXVII)— 510(k) K260191
Substantially EquivalentTianjin Huahong Technology Co., Ltd.
FDA 510(k) clearance K260191 for Safety lancet (XXXVII), Substantially Equivalent on 2026-03-31. Applicant: Tianjin Huahong Technology Co., Ltd.. Device class: 2.
Summary
Tianjin Huahong Technology's Safety lancet (XXXVII) is filed under FMK, single-use blood lancets with an integral sharps injury prevention feature. The name is generic apart from the XXXVII designation.
Class II, 21 CFR 878.4850. General and Plastic Surgery is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Tianjin Huahong Technology filed from Tianjin, China. Review took 68 calendar days (January 22 to March 31, 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.