FDA applicant

Timpel S.A.

Sao Paulo, BR4 decisions2018–20250 recalls

FDA records 4 decisions for Timpel S.A. (Sao Paulo, BR) from 2018 to 2025: 3 510(k) clearances and 1 De Novo grant. All are in product code QEB (Ventilatory Electrical Impedance Tomograph). Its devices cite 4 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Timpel, Inc.”.

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 Timpel S.A.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

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

Planning a device like Timpel S.A.’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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Timpel S.A.

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?