510(k) K261399
K261399 is an FDA 510(k) premarket notification submitted by Nipro Medical Corporation for the device "ELISIO-HX". The FDA issued a decision of Substantially Equivalent on July 28, 2026. The device falls under product code QAX (Hemodialyzer With Expanded Solute Removal Profile), a Class II device regulated under 21 CFR 876.5862. Nipro Medical Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 2026
- Date Received
- April 29, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hemodialyzer With Expanded Solute Removal Profile
- Device Class
- Class II
- Regulation Number
- 876.5862
- Review Panel
- GU
- Submission Type
A hemodialyzer with expanded solute removal profile is intended for use as part of an artificial kidney system for the treatment of patients with renal failure by performing such therapies as hemodialysis, hemofiltration, and hemodiafiltration. A hemodialyzer with expanded solute removal profile includes modifications to the semipermeable membrane that allows for increased removal of uremic retention solutes compared with standard high-flux hemodialyzers of the high permeability hemodialysis system classification (21 CFR §876.5860), including solutes at the upper end of the middle molecular weight range (0.5 kDa to 60 kDa).