# K212100: Kosmos

- Pathway: 510(k) (Traditional)
- Applicant: EchoNous, Inc.
- Decided: Aug 6, 2021 after 31 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 22 generations back to K935595 (1995). 159 ancestors in all.
No later device cites it as a predicate yet.
0 of 160 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193518: Kosmos, EchoNous, Inc. (2020) Summary page 5.

## Recalls of this device
- May 9, 2024 · Class II · Z-2325-2024: Ultrasound system has a bug in affected iOS software, which after DICOM export, can cause inaccuracy in postprocessed measurements done in 3rd party software, such as PACS or other post-processing sof

## Indications for use
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 capabilities, 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 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. The device is non-invasive, reusable, and intended to be used on one patient at a time.

Source page: https://510kreport.com/device/K212100
Methodology: https://510kreport.com/methodology