510(k) Report

FDA applicant

Neuralytix, LLC

Fruita, CO2 decisions2025–20260 recalls

FDA records 2 decisions for Neuralytix, LLC (Fruita, CO) from 2025 to 2026: 2 510(k) clearances. All are in product code PDQ (Neurosurgical Nerve Locator). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Neuralytix”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ear, nose and throat panel, where it files most

How often FDA has decided Neuralytix, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2025: 12026 (partial year): 1
2025high 1 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — Neuralytix, LLC by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • PDQNeurosurgical Nerve Locator2decisions

Whose devices does it build on?

Its devices cite 2 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.

  • K243636Neuralytix iD3 System (NTX-9001)Neuralytix, LLC · 20251cites it

What has FDA decided for it lately?

  • K260992iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007)Neuralytix · 2026
  • K243636Neuralytix iD3 System (NTX-9001)Neuralytix, LLC · 2025

The one decision as Neuralytix, LLC →The one decision as Neuralytix →