510(k) Report

FDA applicant

Bellco Srl

Mirandola, IT3 decisions2016–20230 recalls

FDA records 3 decisions for Bellco Srl (Mirandola, IT) from 2016 to 2023: 3 510(k) clearances. All are in product code KDI (Dialyzer, High Permeability With Or Without…). Since 2016 its 510(k)s took a median of 263 days from receipt to decision, against 230 for FDA’s reviews in the same codes and years. Its devices cite 5 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 Bellco Srl’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2016: 12020: 12023: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Bellco Srl by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KDIDialyzer, High Permeability With Or Without Sealed Dialysate System3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 263 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 230 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K193542Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22Bellco Srl · 20201cites it

What has FDA decided for it lately?

  • K231406ClearumTM HSBellco Srl · 2023
  • K193542Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22Bellco Srl · 2020
  • K160558Rapido Hollow-Fibre DialyzersBellco Srl · 2016

All 3 as Bellco Srl →

Other applicant names beginning “Bellco”

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

Bellco Artifidial Organ Spec., Inc. 3Bellco Srl (Now Part of Medtronic, Inc) 1