510(k) Report

FDA applicant

Avco Medical Products

Mchenry, IL5 decisions1977–19810 recalls

FDA records 5 decisions for Avco Medical Products (Mchenry, IL) from 1977 to 1981: 5 510(k) clearances. Most are in product codes DSP (System, Balloon, Intra-Aortic And Control) and KFM (Pump, Blood, Cardiopulmonary Bypass…). 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, cardiovascular panel, where it files most

How often FDA has decided Avco Medical Products’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Avco Medical Products since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Avco Medical Products 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?

  • DSPSystem, Balloon, Intra-Aortic And Control4decisions
  • KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type1decision

What has FDA decided for it lately?

  • K802924Kontron Percutaeous Double-LumenAvco Medical Products · 1981
  • K790241Intra-Aortic Balloon-PumpAvco Medical Products · 1979
  • K781848Pump, Balloon Model 10Avco Medical Products · 1979
  • K770937Pump, Bypass, Pulsatile, AvcoAvco Medical Products · 1977
  • K770821Pump, Balloon, Intra-Aortic, Tri-SegmentAvco Medical Products · 1977

All 5 as Avco Medical Products →