510(k) Report

FDA applicant

Bellco Artifidial Organ Spec., Inc.

Mchenry, IL3 decisions1980–19800 recalls

FDA records 3 decisions for Bellco Artifidial Organ Spec., Inc. (Mchenry, IL) in 1980: 3 510(k) clearances. Most are in product codes FHS (Dialyzer, Single Coil) and FJG (Dialyzer, Parallel Flow). 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 Artifidial Organ Spec., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bellco Artifidial Organ Spec., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bellco Artifidial Organ Spec., Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FHSDialyzer, Single Coil1decision
  • FJGDialyzer, Parallel Flow1decision
  • FIENeedle, Fistula1decision

What has FDA decided for it lately?

  • K801633The Bravo New Parallel Flow DialyzerBellco Artifidial Organ Spec., Inc. · 1980
  • K801634The Vita 2 Disposable DialyzerBellco Artifidial Organ Spec., Inc. · 1980
  • K801632The Bellco Fistula NeedlesBellco Artifidial Organ Spec., Inc. · 1980

All 3 as Bellco Artifidial Organ Spec., Inc. →

Other applicant names beginning “Bellco”

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

Bellco Srl 3Bellco Srl (Now Part of Medtronic, Inc) 1