510(k) Report

FDA applicant

Stellate Systems

Westmount, Quebec, CA7 decisions1991–20111 recall

FDA records 7 decisions for Stellate Systems (Westmount, Quebec, CA) from 1991 to 2011: 7 510(k) clearances. Most are in product codes OLV (Standard Polysomnograph With…) and OLT (Non-Normalizing Quantitative…). Its devices cite 2 predicates, 1 of them its own earlier devices. 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, neurology panel, where it files most

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

FDA decisions per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Stellate Systems 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?

  • OLVStandard Polysomnograph With Electroencephalograph2decisions
  • OLTNon-Normalizing Quantitative Electroencephalograph Software2decisions
  • GWQFull-Montage Standard Electroencephalograph1decision
  • GWSAnalyzer, Spectrum, Electroencephalogram Signal1decision
  • OMBAutomatic Event Detection Software For Full-Montage Electroencephalograph1decision

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 1 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.

  • K912938RhythmStellate Systems · 19913cite it
  • K010728Harmone-Schwarzer Eeg SystemStellate Systems · 20012cite it

What has FDA decided for it lately?

  • K083577Harmonie SystemStellate Systems · 20111 recall
  • K013450Notta Ambulatory RecorderStellate Systems · 2002
  • K010728Harmone-Schwarzer Eeg SystemStellate Systems · 20011 recall
  • K982351LUNAStellate Systems · 1998
  • K955577Eclipse Version 3.0Stellate Systems · 1996
  • K960273Harmonie SensaStellate Systems · 1996
  • K912938RhythmStellate Systems · 1991

All 7 as Stellate Systems →

What has been recalled?

1 recall linked to its devices; the latest:

  • K010728Harmonie software versions 5.1 uo to 6.2e : Harmonie-E Long Term Monitoring system…Apr 6, 2009Class II