ELISIO-H— 510(k) K260533
Substantially EquivalentNipro Medical Corporation
FDA 510(k) clearance K260533 for ELISIO-H, Substantially Equivalent on 2026-03-19. Applicant: Nipro Medical Corporation. Device class: 2.
Summary
Nipro Medical's ELISIO-H is filed under KDI, high-permeability dialyzers with or without sealed dialysate system. The record doesn't list dialyzer sizes or models.
Class II, 21 CFR 876.5860. Gastroenterology and Urology is both the classification panel and the review panel. It was a Special 510(k).
Nipro Medical filed from Miami, Florida. The decision came 30 calendar days after receipt (February 17 to March 19, 2026).
Clearance details
- Applicant
- Nipro Medical Corporation
- Product code
- Product code KDI
- Device class
- Class 2
- Regulation
- 21 CFR 876.5860
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Miami, FL, US
Recent devices under product code KDI
view allMore clearances from Nipro Medical Corporation
view allAdverse events under product code KDI
product code KDI- Death
- 352
- Injury
- 1,474
- Malfunction
- 12,534
- Other
- 4
- Total
- 14,364
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.