510(k) Report

FDA applicant

Bellco Srl (Now Part of Medtronic, Inc)

Mirandola, IT1 decision2020–20200 recalls

FDA records 1 decision for Bellco Srl (Now Part of Medtronic, Inc) (Mirandola, IT) in 2020: 1 De Novo grant. All are in product code QIR (Pediatric Hemodialysis System). 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 Bellco Srl (Now Part of Medtronic, Inc)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2020: 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Bellco Srl (Now Part of Medtronic, Inc) by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bellco Srl (Now Part of Medtronic, Inc)’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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Other applicant names beginning “Bellco”

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