# K241051: Vave Wireless Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Vave Health, Inc.
- Decided: Aug 30, 2024 after 135 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
Longest line of descent: 17 generations back to K935595 (1995). 128 ancestors in all.
No later device cites it as a predicate yet.
0 of 129 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191541: Vave Personal Ultrasound System, Vave Health, Inc. (2019) Summary page 4.

## Indications for use
The Vave Wireless Ultrasound System is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body. The Vave Wireless Ultrasound System is intended to be used by qualified and trained healthcare professionals or practitioners that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices. The users may or may not be working under supervision or authority of a physician. Users may also include medical students working under the supervision or authority of a physician during their education / training. The Vave Wireless Ultrasound System is a transportable system that is intended for use in environments where healthcare is provided by trained healthcare professionals (e.g., Hospital, clinic, medical office), home environment, road/air ambulance and other environments where healthcare is provided. The Vave Charger is to be used in a stationary setting. It is indicated for diagnostic ultrasound imaging in the following applications: Ophthalmic, Fetal/Obstetrics, Abdominal (includes Gynecology, Renal, and Urology), Pediatric, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Small Organ (includes Breast, Thyroid, and Scrotum), Thoracic/Pleural, Cardiac Adult, Cardiac Pediatric, Peripheral Vessel and procedural guidance of needles into the body. The operating modes are B mode, M mode, B+M, B+C, CD mode.

Source page: https://510kreport.com/device/K241051
Methodology: https://510kreport.com/methodology