510(k) · Cleared
ClearedKosmos
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
EchoNous, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Aug 29, 2024 after a 272-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Aug 29, 2024
- Review
- 272 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK233826 KosmosEchoNous, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK252558 Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · 2026
Most influential descendants
Showing 1 of 1 · See all- K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K233826 | Kosmos | EchoNous, Inc. | 2024 | — |
| +1 | K252558 | Lumify Diagnostic Ultrasound System | Philips Ultrasound, LLC | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IYN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IYN device
- #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252558 | Lumify Diagnostic Ultrasound System | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K252558 (Philips Ultrasound, LLC, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 2025
MAUDE reports naming product code IYN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 13 | 26 | 16 | 3 |
| 2008 | 25 | 18 | 12 | 2 |
| 2009 | 18 | 29 | 8 | 9 |
| 2010 | 29 | 67 | 10 | 17 |
| 2011 | 39 | 46 | 8 | 18 |
| 2012 | 43 | 37 | 3 | 20 |
| 2013 | 51 | 60 | 8 | 18 |
| 2014 | 56 | 39 | 2 | 48 |
| 2015 | 54 | 55 | 3 | 116 |
| 2016 | 60 | 56 | 2 | 145 |
| 2017 | 64 | 83 | 0 | 146 |
| 2018 | 59 | 85 | 7 | 85 |
| 2019 | 47 | 79 | 0 | 59 |
| 2020 | 57 | 72 | 4 | 67 |
| 2021 | 46 | 105 | 8 | 213 |
| 2022 | 53 | 105 | 10 | 186 |
| 2023 | 44 | 115 | 4 | 229 |
| 2024 | 50 | 119 | 1 | 266 |
| 2025 | 57 | 124 | 10 | 610 |
| 2026 | 44 | 107 | 2 (1) | — |
What is it indicated for?
Kosmos is intended to be used by qualified and trained healthcare professionals in the clinical assessment for the following clinical applications by acquiring, processing, displaying, measuring, and storing ultrasound images, or synchronized ultrasound images, electrocardiogram (ECG) rhythms, and digital auscultation (DA) sounds and waveforms. With respect to its ultrasound imaging capability, Kosmos is a general-purpose diagnostic ultrasound system…
Read the full statement (287 words)
Kosmos is intended to be used by qualified and trained healthcare professionals in the clinical assessment for the following clinical applications by acquiring, processing, displaying, measuring, and storing ultrasound images, or synchronized ultrasound images, electrocardiogram (ECG) rhythms, and digital auscultation (DA) sounds and waveforms.
With respect to its ultrasound imaging capability, Kosmos is a general-purpose diagnostic ultrasound system used in the following clinical applications and modes of operation:
Clinical Applications: Cardiac, Thoracic/Lung, Abdominal, Vascular/Peripheral Vascular, Musculoskeletal, and interventional guidance (includes free hand needle / catheter placement fluid drainage, and nerve block)
Modes of Operation: B-mode, M-mode, Color Doppler, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Combined Modes of B+M, and B+CD, B+PW, B+CW, and Harmonic Imaging
Kosmos is intended to be used in clinical care and medical education settings on adult and pediatric patient populations. Kosmos includes the AI-assisted automated ejection fraction software, known as Auto EF, which is used to process previously acquired transthoracic cardiac ultrasound images, to store images, and to manipulate and make measurements on images using the Kosmos, Auto EF provides automated estimation of left ventricular ejection fraction. This measurement can be used to assist the clinician in a cardiac evaluation. Auto EF is indicated for use on adult patients only in healthcare facilities.
The Kosmos includes the Auto Anatomical Structure Labeling and View Identification, also referred to as AI FAST, software, which is intended for use only by qualified and trained medical professionals for automatic real-time detection and labeling of anatomical structures during image acquisition during cardiac, thoracic/lung, or abdominal ultrasound imaging. This feature is only indicated for use on adult patients in healthcare facilities.
The device is non-invasive, reusable, and intended to be used on one patient at a time.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K233826 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233826: Kosmos.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233826
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026