510(k) Report

FDA applicant

Vave Health, Inc.

San Jose, CA2 decisions2019–20240 recalls

FDA records 2 decisions for Vave Health, Inc. (San Jose, CA) from 2019 to 2024: 2 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and IYO (System, Imaging, Pulsed Echo, Ultrasonic). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Vave Health, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2019: 12024: 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Vave Health, Inc. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Vave Health, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic1decision
  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic1decision

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K191541Vave Personal Ultrasound SystemVave Health, Inc. · 20191cites it

What has FDA decided for it lately?

  • K241051Vave Wireless Ultrasound SystemVave Health, Inc. · 2024
  • K191541Vave Personal Ultrasound SystemVave Health, Inc. · 2019

All 2 as Vave Health, Inc. →