ELISIO-HX— 510(k) K261399
Substantially EquivalentNipro Medical Corporation
FDA 510(k) clearance K261399 for ELISIO-HX, Substantially Equivalent on 2026-07-28. Applicant: Nipro Medical Corporation. Device class: 2.
Summary
Nipro Medical's ELISIO-HX is filed under QAX, hemodialyzers with expanded solute removal profile. The record doesn't give membrane area or other specs.
Class II, 21 CFR 876.5862. Gastroenterology and Urology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Nipro filed from Miami, Florida. Review took 90 calendar days (April 29 to July 28, 2026).
Clearance details
- Applicant
- Nipro Medical Corporation
- Product code
- Product code QAX
- Device class
- Class 2
- Regulation
- 21 CFR 876.5862
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, US
Recent devices under product code QAX
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