510(k) K182940 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Surdial DX Hemodialysis System
| Applicant | Nipro Medical Corporation, Miami FL, US |
| Decision | Substantially Equivalent, Jul 19, 2019 |
| Received | Oct 23, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182940
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 11, 2025 | Nipro Medical Corporation Hemodialysis System, Surdial DX
REF: MC+SDX01
Rx Only Open, Classified |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.