FDA applicant

VivaQuant, Inc.

St. Paul, MN3 decisions2019–20250 recalls

FDA records 3 decisions for VivaQuant, Inc. (St. Paul, MN) from 2019 to 2025: 3 510(k) clearances. Most are in product codes MLO (Electrocardiograph, Ambulatory, With Analysis…) and DXH (Transmitters And Receivers…). Its devices cite 4 predicates, 2 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2025

2019high 1 (2019) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

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

Planning a device like VivaQuant, 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

Other applicant names beginning “VivaQuant”

FDA records each applicant name separately; these may or may not be the same firm.

Vivaquant, Inc. Dba Rhythm Express 1

VivaQuant, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “VivaQuant”