Elisio-Hx
FDA 510(k) K261399 · Nipro Medical Corporation
510(k) numberK261399
Submission
- Device name
- Elisio-Hx
- Applicant
- Nipro Medical Corporation
Miami, FL, US - Received
- April 29, 2026
- Decision date
- July 28, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QAX – Hemodialyzer With Expanded Solute Removal Profile
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5862
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
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…
More from Nipro Medical Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K253047 | PressoneFMI · Traditional | 03/24/2026SE |
| K260533 | Elisio-HKDI · Special | 03/19/2026SE |
| K222852 | Nipro SafeTouch Needle; Nipro Syringe with SafeTouch NeedleFMI · Traditional | 05/25/2023SE |
| K212677 | aboNT SYRINGEFMF · Traditional | 04/15/2022SE |
| K190037 | Cronus HP PTA Balloon CatheterLIT · Traditional | 10/24/2019SE |
| K191359 | Nipro SyringeFMF · Traditional | 10/09/2019SE |
| K182940 | Surdial DX Hemodialysis SystemKDI · Traditional | 07/19/2019SE |
| K173029 | Nipro SyringeFMF · Traditional | 03/30/2018SE |
| K161681 | Nipro SafeTouch IV CatheterFOZ · Traditional | 03/08/2017SE |
| K160444 | FB-U HemodialyzerKDI · Traditional | 02/08/2017SE |
Questions and answers
When was Elisio-Hx cleared by the FDA?
Elisio-Hx (K261399) received a 510(k) decision of Substantially Equivalent on July 28, 2026, 90 days after the submission was received.
What is the product code of K261399?
The FDA product code is QAX – Hemodialyzer With Expanded Solute Removal Profile, a Class II (moderate risk) device regulated under 21 CFR 876.5862.