510(k) K253412 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Tablo Hemodialysis System (PN-0008000, PN-0006000U)
| Applicant | Outset Medical, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, Jan 26, 2026 |
| Received | Sep 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253412
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.