510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K041826Unknown

Ekos Ultrasound Infusion System

Ekos Corp., Bothell WA / Traditional, Unknown
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K041826 is the FDA 510(k) clearance record for EKOS ULTRASOUND INFUSION SYSTEM, a class II device, cleared for Ekos Corp. on under FDA product code NUI (Ultrasound, Infusion, System). FDA's definition for product code NUI reads: "For regional infusion of contrast materials into selected vessels in the neuro-vasculature. The device may be used for controlled, regional infusion into selected vessels and is not intended for use in the coronary vasculature". FDA records list 25 510(k) clearances for Ekos Corp., from to . As of , FDA records show no recalls naming K041826.

Clearance record

Decision date
Received
(294 days to decision)
Product code
NUI Ultrasound, Infusion, System
Regulation
21 CFR 870.1200
Device class
Class II
Review panel
Cardiovascular
Applicant
Ekos Corp. 22030 20th Ave. SE, Bothell WA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NUI

Trailing 12 months

FDA records hold no clearances under product code NUI in the trailing twelve months.

FDA records show no clearances under product code NUI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NUI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260