510(k) Report

FDA applicant

Tni Medical AG

Wuerzburg, DE1 decision2018–20180 recalls

FDA records 1 decision for Tni Medical AG (Wuerzburg, DE) in 2018: 1 510(k) clearance. All are in product code BTT (Humidifier, Respiratory Gas, (Direct Patient…). 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, anesthesiology panel, where it files most

How often FDA has decided Tni Medical AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2018: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Tni Medical AG by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • BTTHumidifier, Respiratory Gas, (Direct Patient Interface)1decision

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?

  • K180474TNI softFlow 50Tni Medical AG · 2018

The one decision as Tni Medical AG →