Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)— 510(k) K252490
Substantially EquivalentTianjin Huahong Technology Co., Ltd.
FDA 510(k) clearance K252490 for Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV), Substantially Equivalent on 2026-02-12. Applicant: Tianjin Huahong Technology Co., Ltd.. Device class: 2.
Summary
Tianjin Huahong Technology's Heel Stick Safety Lancet lists three models: HHZ-II, HHZ-III, and HHZ-IV. It's filed under product code FMK (Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature), and the record doesn't say how they differ.
Class II, 21 CFR 878.4850. General, Plastic Surgery is both the classification panel and the review panel, and it came in as a Special 510(k).
Tianjin Huahong Technology filed from Tianjin, China. The decision came 188 calendar days after FDA received it (August 8, 2025 to February 12, 2026), and it was substantially equivalent.
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
- Special
- 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.