FDA applicant

Neuro Kinetics, Inc.

Pittsburgh, PA4 decisions2009–20184 recalls

FDA records 4 decisions for Neuro Kinetics, Inc. (Pittsburgh, PA) from 2009 to 2018: 4 510(k) clearances. All are in product code GWN (Nystagmograph). Its devices cite 4 predicates, 4 of them its own earlier devices. 4 recalls are linked to its devices.

FDA’s records also spell it “Neuro Kinetics”.

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 Neuro Kinetics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

2in 2015

2009high 2 (2015) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Neuro Kinetics, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Neuro Kinetics, 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

Other applicant names beginning “Neuro”

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

Neuro Navigational Corp. 23 Neuro Supplies, Inc. 5 Neuro Technology 5 Neuro Resource Group, Inc. 4 Neuro Therm, Inc. 3 Neuro Scan Labs 3 Neuro Vasx, Inc. 2 Neuro-Biometrix, Inc. 2 Neuro-Diagnostic Assoc. 2 Neuro Event Labs OY 1 Neuro-Fitness, LLC 1 Neuro Diagnostic Devices 1

Neuro Kinetics, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Neuro”