510(k) Report

FDA applicant

Novacon Corp.

St.Paul, MN6 decisions1994–19990 recalls

FDA records 6 decisions for Novacon Corp. (St.Paul, MN) from 1994 to 1999: 6 510(k) clearances. All are in product code MEB (Pump, Infusion, Elastomeric). 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Novacon Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Novacon Corp. 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?

  • MEBPump, Infusion, Elastomeric6decisions

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.

  • K960318Dib Infusor-RANovacon Corp. · 19961cites it

What has FDA decided for it lately?

  • K992015Freedom Infusion SystemNovacon Corp. · 1999
  • K955849Dib InfusorNovacon Corp. · 1996
  • K960318Dib Infusor-RANovacon Corp. · 1996
  • K944665Dib InfusorsNovacon Corp. · 1995
  • K941766Dib InfusorNovacon Corp. · 1994
  • K930404Dib InfusorNovacon Corp. · 1994

All 6 as Novacon Corp. →