510(k) Report

FDA applicant

Itp Innovative Tomography Products GmbH

Bochum, DE2 decisions2023–20240 recalls

FDA records 2 decisions for Itp Innovative Tomography Products GmbH (Bochum, DE) from 2023 to 2024: 2 510(k) clearances. All are in product code KNW (Instrument, Biopsy). Its devices cite 2 predicates, 1 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 Itp Innovative Tomography Products GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2023: 12024: 1
2023high 1 (2023) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

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

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