# K242321: Kosmos

- Pathway: 510(k) (Traditional)
- Applicant: EchoNous, Inc.
- Decided: Apr 25, 2025 after 262 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Kosmos is intended to be used by qualified and trained healthcare professionals in the clinical assessment of the cardiac and pulmonary systems and the abdomen by acquiring, processing, displaying, measuring, and storing ultrasound images. With respect to its ultrasound imaging capabilities, Kosmos is a general purpose diagnostic ultrasound system used in the following clinical applications and modes of operation: Clinical Applications and Modes of Operation for Kosmos on Android • Clinical applications: Torso-One: Cardiac, Thoracic/Lung, Abdominal, and Obstetrics /Gynecology. Lexsa: Lung, Vascular/Peripheral Vascular, Musculoskeletal, Nerve and image Guidance for Needle/Catheter Placement (includes needle/ catheter placement, fluid drainage, and nerve block) • Modes of operation: B-mode, M-mode, Color Doppler, Color Power Doppler, combined modes of B+M and B+CD, PW Doppler, CW Doppler, TDI, and Harmonic Imaging. Kosmos is intended to be used in clinical care and medical education settings on adult and pediatric patient populations. The device is non-invasive, reusable, and intended to be used on one patient at a time.

Source page: https://510kreport.com/device/K242321
Methodology: https://510kreport.com/methodology