Cleared Traditional

K233826 - Kosmos (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence.

K233826 · EchoNous, Inc. · Radiology device
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Aug 2024
Decision
272d
Days
Class 2
Risk

K233826 is an FDA 510(k) clearance for the Kosmos. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by EchoNous, Inc. (Redmond, US). The FDA issued a Cleared decision on August 29, 2024 after a review of 272 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all EchoNous, Inc. devices

Submission Details

510(k) Number K233826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2023
Decision Date August 29, 2024
Days to Decision 272 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
165d slower than avg
Panel avg: 107d · This submission: 272d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Radiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT06027164 Completed Observational Industry-sponsored

Kosmos Trio and Ejection Fraction Pivotal Study

153
Patients (actual)
1
Site
Condition studied Cardiac Disease
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Sponsor EchoNous Inc. (industry)
Started 2023-08-04 → Primary completion 2023-08-31 → Completed 2024-05-16
Primary outcome
Assessment of Global Left Ventricular Function
Secondary outcome
Assessment of Automatic Structure Labelling
Study completed - no results published. This trial concluded in 2024 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 1158
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K233826.
ES-Series
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EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
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