510(k) Report

FDA applicant

Compremium AG

Muri, CH1 decision2023–20230 recalls

FDA records 1 decision for Compremium AG (Muri, CH) in 2023: 1 510(k) clearance. All are in product code LXC (Monitor, Pressure, Intracompartmental). 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

How often FDA has decided Compremium AG’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 — Compremium AG by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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