510(k) Report

FDA applicant

Diopsys, Inc.

Pine Brook, NJ2 decisions2005–20111 recall

FDA records 2 decisions for Diopsys, Inc. (Pine Brook, NJ) from 2005 to 2011: 2 510(k) clearances. All are in product code GWE (Stimulator, Photic, Evoked Response). Its devices cite 4 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 Diopsys, Inc.’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 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Diopsys, 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?

  • GWEStimulator, Photic, Evoked Response2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K043491EnfanttmDiopsys, Inc. · 20051cites it

What has FDA decided for it lately?

  • K101763Diopsys Nova Vep Vision Testing SystemDiopsys, Inc. · 2011
  • K043491EnfanttmDiopsys, Inc. · 20051 recall

All 2 as Diopsys, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K043491Diopsys Inc., Enfant Pediatric VEP Vision Testing System, Input: 120 Vac, 60Hz/2.5A IEC…Apr 2, 2007