510(k) Report

FDA applicant

Innovative Medical Systems, Inc.

Mchenry, IL23 decisions1978–19980 recalls

FDA records 23 decisions for Innovative Medical Systems, Inc. (Mchenry, IL) from 1978 to 1998: 22 510(k) clearances and 1 original PMA approval. Most are in product codes IEO (Processor, Tissue, Automated) and KPA (Slide Stainer, Automated). 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, pathology panel, where it files most

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

FDA decisions per year

No FDA decision for Innovative Medical Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Innovative Medical Systems, 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?

  • IEOProcessor, Tissue, Automated5decisions
  • KPASlide Stainer, Automated4decisions
  • JQWStation, Pipetting And Diluting, For Clinical Use3decisions
  • HQCUnit, Phacofragmentation2decisions
  • MTVSharps Needle Destruction Device1decision
  • GLEMixer, Blood Tube1decision

Also: EIA (1), GKR (1), BZD (1), GKH (1), JJQ (1), FNM (1).

Who builds on its devices?

Later devices cite its devices 4 times; 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.

  • K915456Phaco 3000 LinearInnovative Medical Systems, Inc. · 19921cites it
  • K915457Phaco 20/20 System IInnovative Medical Systems, Inc. · 19921cites it
  • K933184Positive Airway Pressure SystemInnovative Medical Systems, Inc. · 19941cites it
  • K922081Labotech Automated Microtiter AnalyzerInnovative Medical Systems, Inc. · 19921cites it

What has FDA decided for it lately?

  • P980015SharpxInnovative Medical Systems, Inc. · 1998
  • K973035Viola II Dental Camera SystemInnovative Medical Systems, Inc. · 1997
  • K951469Bazooka SystemInnovative Medical Systems, Inc. · 1995
  • K933184Positive Airway Pressure SystemInnovative Medical Systems, Inc. · 1994
  • K924590Microwave Automated Tissue ProcessorInnovative Medical Systems, Inc. · 1992
  • K922081Labotech Automated Microtiter AnalyzerInnovative Medical Systems, Inc. · 1992
  • K921005AutoloaderInnovative Medical Systems, Inc. · 1992
  • K915457Phaco 20/20 System IInnovative Medical Systems, Inc. · 1992

All 23 as Innovative Medical Systems, Inc. →