510(k) Report

FDA applicant

Copan Wasp Srl

Brescia, IT5 decisions2021–20260 recalls

FDA records 5 decisions for Copan Wasp Srl (Brescia, IT) from 2021 to 2026: 5 510(k) clearances. Most are in product codes QQV (Automated System For Sample Preparation And…) and LON (System, Test, Automated, Antimicrobial…). Its devices cite 7 predicates, 2 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, microbiology panel, where it files most

How often FDA has decided Copan Wasp Srl’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2021: 12022: 12023: 22026 (partial year): 1
2021high 2 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Copan Wasp Srl by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Copan”

FDA records each applicant name separately; these may or may not be the same firm.