510(k) Report

FDA applicant

I3 Membrane GmbH

Radeberg, DE1 decision2023–20230 recalls

FDA records 1 decision for I3 Membrane GmbH (Radeberg, DE) in 2023: 1 510(k) clearance. All are in product code NHV (System, Water Purification, General Medical Use). Its devices cite 1 predicate, 0 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, gastroenterology and urology panel, where it files most

How often FDA has decided I3 Membrane GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023: 1
2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — I3 Membrane GmbH by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NHVSystem, Water Purification, General Medical Use1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K222727i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S)I3 Membrane GmbH · 2023

The one decision as I3 Membrane GmbH →