510(k) Report

FDA applicant

Nicolet Biomedical, Inc.

Stoughton, WI18 decisions1995–200310 recalls

FDA records 18 decisions for Nicolet Biomedical, Inc. (Stoughton, WI) from 1995 to 2003: 18 510(k) clearances. Most are in product codes GWQ (Full-Montage Standard Electroencephalograph) and IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Its devices cite 22 predicates, 2 of them its own earlier devices. 10 recalls are linked to its devices.

FDA’s records also spell it “Nicolet Biomedical”.

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 Nicolet Biomedical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Nicolet Biomedical, Inc. since 2007.

Recalls per year

4in 2017

2008: 32010: 12017: 4
2007high 4 (2017) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Nicolet Biomedical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Nicolet Biomedical, Inc.’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?

  • GWQFull-Montage Standard Electroencephalograph2decisions
  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic2decisions
  • JAFMonitor, Ultrasonic, Nonfetal2decisions
  • OLWIndex-Generating Electroencephalograph Software1decision
  • IKTElectrode, Needle, Diagnostic Electromyograph1decision
  • LLZSystem, Image Processing, Radiological1decision

Also: GYC (1), GXY (1), ETN (1), GXZ (1), OMB (1), JOP (1).

Whose devices does it build on?

Its devices cite 22 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 21 times; 2 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.

  • K991054Bravo Multi-Modality SystemNicolet Biomedical, Inc. · 19999cite it
  • K010019Sterile Subdermal Needle ElectrodesNicolet Biomedical, Inc. · 20013cite it
  • K020218Snap Eeg MonitorNicolet Biomedical, Inc. · 20021cites it
  • K011818Sterile Emg ElectrodesNicolet Biomedical, Inc. · 20011cites it
  • K013419Nicolet Electromagnetic Navigation SystemNicolet Biomedical · 20011cites it
  • K021144Subdural Strip ElectrodeNicolet Biomedical, Inc. · 20021cites it

What has FDA decided for it lately?

  • K020754Nicolet Pioneer TC8080Nicolet Biomedical · 2003
  • K021986BrainetNicolet Biomedical, Inc. · 2002
  • K021144Subdural Strip ElectrodeNicolet Biomedical, Inc. · 2002
  • K020218Snap Eeg MonitorNicolet Biomedical, Inc. · 2002
  • K013281Versalab ApmNicolet Biomedical · 2002
  • K020955Nicolet Electrocautery DetectorNicolet Biomedical, Inc. · 2002
  • K013419Nicolet Electromagnetic Navigation SystemNicolet Biomedical · 2001
  • K011818Sterile Emg ElectrodesNicolet Biomedical, Inc. · 2001

All 10 as Nicolet Biomedical, Inc. →All 8 as Nicolet Biomedical →

What has been recalled?

10 recalls linked to its devices; the latest:

  • K982635Nicolet¿ Elite¿ 2 MHz OB Water Proof Probe, Model #: X1L008, Catalog Code: NW20.…Jun 9, 2017Class II
  • K982635Nicolet¿ Elite¿ 2 MHz OB Probe, Non-Fetal Monitor, Model #: X1L007, Catalog Code: N200.…Jun 9, 2017Class II
  • K982635Nicolet¿ Elite¿ 3 MHz OB Probe, Model #: X1L001, Catalog Code: N300. Intended for…Jun 9, 2017Class II
  • K982635Nicolet¿ Elite¿ 5 MHz Vascular Probe, Model #: X1L004, Catalog Code: N500. Intended for…Jun 9, 2017Class II
  • K991054NicoletOne vEEG System, VIASYS Healthcare, Inc., Madison, Wisconsin 53711.Mar 8, 2010
  • K011135GSI Audera (version 2.6 software) Viasys Healthcare, Inc. Part or (Catalog) Numbers…Sep 16, 2008

Other applicant names beginning “Nicolet”

FDA records each applicant name separately; these may or may not be the same firm.

Nicolet Biomedical Instruments 26Nicolet Instrument Corp. 13