Safety Heel Lancet— 510(k) K253605
Substantially EquivalentNingbo Medsun Medical Co., Ltd.
FDA 510(k) clearance K253605 for Safety Heel Lancet, Substantially Equivalent on 2026-02-20. Applicant: Ningbo Medsun Medical Co., Ltd.. Device class: 2.
Summary
Ningbo Medsun Medical's Safety Heel Lancet is filed under product code FMK (Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature). The record doesn't describe the lancet beyond its name and that code name.
Class II, 21 CFR 878.4850. General, Plastic Surgery is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Ningbo Medsun Medical filed from Ningbo, China. The substantially equivalent decision came 94 calendar days after receipt (November 18, 2025 to February 20, 2026).
Clearance details
- Applicant
- Ningbo Medsun Medical 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
- Ningbo, CN
Recent devices under product code FMK
view allMore clearances from Ningbo Medsun Medical 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.