510(k) K262631 ยท QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)
| Applicant | SteriLance Medical (Suzhou), Inc., Suzhou, CN |
| Decision | Substantially Equivalent, Aug 25, 2026 |
| Received | Jul 29, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K262631
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.