510(k) K253605 ยท FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Safety Heel Lancet
| Applicant | Ningbo Medsun Medical Co., Ltd., Ningbo, CN |
| Decision | Substantially Equivalent, Feb 20, 2026 |
| Received | Nov 18, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253605
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.