510(k) Report

FDA applicant

Ice Neurosystems, Inc.

Washington, DC3 decisions2020–20220 recalls

FDA records 3 decisions for Ice Neurosystems, Inc. (Washington, DC) from 2020 to 2022: 3 510(k) clearances. Most are in product codes GZL (Electrode, Depth) and GWQ (Full-Montage Standard Electroencephalograph). Since 2016 its 510(k)s took a median of 262 days from receipt to decision, against 216 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 1 of them its own earlier devices. No 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 Ice Neurosystems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2020: 12021: 12022: 1
2020high 1 (2020) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Ice Neurosystems, Inc. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ice Neurosystems, 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?

  • GZLElectrode, Depth2decisions
  • GWQFull-Montage Standard Electroencephalograph1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 262 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 216 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 5 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.

  • K201678iCE-SG Subcutaneous Electrode ArraysIce Neurosystems, Inc. · 20211cites it

What has FDA decided for it lately?

  • K222706iCE-SG2 Subcutaneous Electrode KitIce Neurosystems, Inc. · 2022
  • K201678iCE-SG Subcutaneous Electrode ArraysIce Neurosystems, Inc. · 2021
  • K191868iCEWav Neuromonitoring PlatformIce Neurosystems, Inc. · 2020

All 3 as Ice Neurosystems, Inc. →