510(k) Report

FDA applicant

Physiometrix, Inc.

North Billerica, MA22 decisions1992–20053 recalls

FDA records 22 decisions for Physiometrix, Inc. (North Billerica, MA) from 1992 to 2005: 22 510(k) clearances. Most are in product codes GXY (Electrode, Cutaneous) and GWQ (Full-Montage Standard Electroencephalograph). Its devices cite 12 predicates, 11 of them its own earlier devices. 3 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 Physiometrix, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Physiometrix, Inc. since 2007.

Recalls per year

3in 2019

2019: 3
2007high 3 (2019) · low 0 (2007)2026

Class I Class II/III not classified

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

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

See the 510(k) Report

Which product codes does it file in?

  • GXYElectrode, Cutaneous7decisions
  • GWQFull-Montage Standard Electroencephalograph5decisions
  • OLWIndex-Generating Electroencephalograph Software4decisions
  • DRXElectrode, Electrocardiograph2decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories2decisions
  • IKDCable, Electrode1decision

Also: GYB (1).

Whose devices does it build on?

Its devices cite 12 predicates; 11 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 15 times; 11 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.

  • K930080E*Net Neuromonitoring SystemPhysiometrix, Inc. · 19936cite it
  • K020670Model 4310 PSARRAY2 Eeg ElectrodePhysiometrix, Inc. · 20021cites it
  • K962447Equinox Digital Eeg SystemPhysiometrix, Inc. · 19961cites it
  • K033999Sedline with Frontal PsiPhysiometrix, Inc. · 20041cites it
  • K970694Model 1700, Hydro PrepPhysiometrix, Inc. · 19971cites it
  • K960732Hydrospot Eeg Electrode Model 1501, Hydrospot Leadwire Model 1500Physiometrix, Inc. · 19961cites it

What has FDA decided for it lately?

  • K051874Sedline Sedation Monitor with Frontal Psi and Sedtrace Eeg Electrose SetPhysiometrix, Inc. · 2005
  • K033999Sedline with Frontal PsiPhysiometrix, Inc. · 2004
  • K020670Model 4310 PSARRAY2 Eeg ElectrodePhysiometrix, Inc. · 2002
  • K020671PSA4000 Eeg Monitor with Frontal PsiPhysiometrix, Inc. · 2002
  • K001069Model 4000 Eeg Monitor with Psi (PSA4000)Physiometrix, Inc. · 2000
  • K001055Model 4300 Psarray Eeg Electrode SetPhysiometrix, Inc. · 2000
  • K970942Model 1320, Neurolink II Neuromonitoring SystemPhysiometrix, Inc. · 1997
  • K970694Model 1700, Hydro PrepPhysiometrix, Inc. · 19973 recalls

All 22 as Physiometrix, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K970694Cognision, Subject Kit (Clinical Grade), Model 3000- containing Hydro Dot brand Wave…Nov 7, 2019Class II
  • K970694HydroDot brand: Wave Prep 4 oz. tubes-Product 1710-03. An electroconductive cream for…Oct 29, 2019Class II
  • K970694HydroDot brand: Wave Prep Single use cups, 8.5 gm (0.3 oz) 24/box-Product 1700-24 -…Oct 29, 2019Class II