510(k) Report

FDA applicant

Bio-Logic Systems Corp.

Mudelein, IL45 decisions1981–20122 recalls

FDA records 45 decisions for Bio-Logic Systems Corp. (Mudelein, IL) from 1981 to 2012: 45 510(k) clearances. Most are in product codes EWO (Audiometer) and GWJ (Stimulator, Auditory, Evoked Response). Its devices cite 27 predicates, 19 of them its own earlier devices. 2 recalls are 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 Bio-Logic Systems Corp.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2012

2008: 12012: 2
2007high 2 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2007

2007: 2
2007high 2 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Bio-Logic Systems Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bio-Logic Systems Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • EWOAudiometer9decisions
  • GWJStimulator, Auditory, Evoked Response7decisions
  • GWQFull-Montage Standard Electroencephalograph5decisions
  • GWEStimulator, Photic, Evoked Response4decisions
  • GWFStimulator, Electrical, Evoked Response3decisions
  • OLVStandard Polysomnograph With Electroencephalograph3decisions

Also: GXY (2), GWN (2), IKN (2), GWK (2), MNR (2), ETW (1).

Whose devices does it build on?

Its devices cite 27 predicates; 19 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 48 times; 19 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.

  • K994149Modification to Bio-Logic Evoked Potential for Abaer/ Navigator Pro.Bio-Logic Systems Corp. · 19994cite it
  • K021895Bio-Logic Master Evoked Response SystemBio-Logic Systems Corp. · 20023cite it
  • K974076Sport/Audx Oae Test Instrument with Bio-Logic Ear ProbeBio-Logic Systems Corp. · 19983cite it
  • K021801Bio-Logic Abaer Cub with Integrated Oae & Abr FunctionsBio-Logic Systems Corp. · 20023cite it
  • K964132Modification to Otoacoustic Emissions (OAE0 Test InstrumentBio-Logic Systems Corp. · 19973cite it
  • K962103Bio-Logic Sleepscan Product with Built-in OximeterBio-Logic Systems Corp. · 19963cite it

What has FDA decided for it lately?

  • K122496Audx Pro Otoacoustic Emissions Measurement SystemBio-Logic Systems Corp. · 2012
  • K121512Scout Sport Otoacoustic Emissions Measurement SystemBio-Logic Systems Corp. · 2012
  • K073626Bio-Logic Master II Evoked Response SystemBio-Logic Systems Corp. · 2008
  • K061744Cochlea-Scan / Cochlea-Scan PlusBio-Logic Systems Corp. · 2006
  • K052066Ceegraph/Sleepscan Netlink TravelerBio-Logic Systems Corp. · 20052 recalls
  • K031352Bio-Logic Insert EarphonesBio-Logic Systems Corp. · 2003
  • K030907Stacked Abr for Navigator ProBio-Logic Systems Corp. · 2003
  • K031009Modification to Bio-Logic Evoked Potential (EP) SystemBio-Logic Systems Corp. · 2003

All 45 as Bio-Logic Systems Corp. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K052066Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and…Jul 26, 2007
  • K052066Bio-logic-Ceegraph/Sleepscan Netlink Traveler, Bio-logic Systems Corp., a nebus company…Feb 26, 2007