FDA applicant

Vivonic GmbH

Sailauf, DE2 decisions2014–20158 recalls

FDA records 2 decisions for Vivonic GmbH (Sailauf, DE) from 2014 to 2015: 2 510(k) clearances. All are in product code FIP (Subsystem, Water Purification). Its devices cite 4 predicates, 0 of them its own earlier devices. 8 recalls are linked to its devices.

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

FIG. A — Illustration, gastroenterology and urology panel, where it files most

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

FDA decisions per year

1in 2015

2014high 1 (2014) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

1in 2024

2014high 4 (2022) · low 0 (2014)2026

Class I Class II/III not classified

FIG. 1 — Vivonic GmbH by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Vivonic GmbH’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

Vivonic GmbH

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?