510(k) Report

FDA applicant

Bionomy, Inc.

Mchenry, IL5 decisions1981–19851 recall

FDA records 5 decisions for Bionomy, Inc. (Mchenry, IL) from 1981 to 1985: 5 510(k) clearances. Most are in product codes DYG (Catheter, Flow Directed) and DXE (Catheter, Embolectomy). 1 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, cardiovascular panel, where it files most

How often FDA has decided Bionomy, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bionomy, Inc. since 2007.

Recalls per year

1in 2025

2025: 1
2007high 1 (2025) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Bionomy, 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?

  • DYGCatheter, Flow Directed2decisions
  • DXECatheter, Embolectomy1decision
  • GBXCatheter, Irrigation1decision
  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K832023Embolectomy CatheterBionomy, Inc. · 19831cites it

What has FDA decided for it lately?

  • K851101Bionomy's Multi-Lumen Central Venous Catheter-SetBionomy, Inc. · 1985
  • K844094Pruitt Irrigation and Occlusion CatheterBionomy, Inc. · 1984
  • K832023Embolectomy CatheterBionomy, Inc. · 1983
  • K812111Pruitt Arterial Occlusion Cholang. CathBionomy, Inc. · 1981
  • K811276Occlusion CatheterBionomy, Inc. · 19811 recall

All 5 as Bionomy, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K811276Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36…Apr 11, 2025Class II