510(k) K254160 ยท OKO Negative Pressure Wound Therapy Non-Powered Suction Apparatus
VacHeal Negative Pressure Wound Therapy System
| Applicant | VacHeal, LLC, Ardmore PA, US |
| Decision | Substantially Equivalent, Sep 18, 2026 |
| Received | Dec 22, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254160
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.