510(k) K251646 · OMP Negative Pressure Wound Therapy Powered Suction Pump
extriCARE® 1000 Negative Pressure Wound Therapy System
| Applicant | Alleva Medical Devices, Brea CA, US |
| Decision | Substantially Equivalent, Oct 3, 2025 |
| Received | May 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251646
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.