510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K261399Substantially Equivalent

Elisio™-Hx

Nipro Medical Corporation, Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K261399 is the FDA 510(k) clearance record for ELISIO™-HX, a class II device, cleared for Nipro Medical Corporation on under FDA product code QAX (Hemodialyzer With Expanded Solute Removal Profile). FDA's definition for product code QAX reads: "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...". FDA records list 62 510(k) clearances for Nipro Medical Corporation, from to . As of , FDA records show no recalls naming K261399.

Clearance record

Decision date
Received
(90 days to decision)
Product code
QAX Hemodialyzer With Expanded Solute Removal Profile
Regulation
21 CFR 876.5862
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Nipro Medical Corporation 3150 NW 107th Ave., Miami FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QAX

Trailing 12 months
1 clearance under product code QAX in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QAX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260