510(k) Report

FDA applicant

Cadwell Industries, Inc.

Kennewick, WA13 decisions2014–20263 recalls

FDA records 13 decisions for Cadwell Industries, Inc. (Kennewick, WA) from 2014 to 2026: 13 510(k) clearances. Most are in product codes GWQ (Full-Montage Standard Electroencephalograph) and GWF (Stimulator, Electrical, Evoked Response). Since 2016 its 510(k)s took a median of 146 days from receipt to decision, against 177 for FDA’s reviews in the same codes and years. Its devices cite 28 predicates, 5 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 Cadwell Industries, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2014: 12016: 12017: 22018: 22019: 12020: 22023: 12024: 12025: 12026 (partial year): 1
2014high 2 (2017) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

1in 2026

2024: 22026 (partial year): 1
2014high 2 (2024) · low 0 (2014)2026

Class I Class II/III not classified

FIG. 1 — Cadwell Industries, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cadwell Industries, 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?

  • GWQFull-Montage Standard Electroencephalograph4decisions
  • GWFStimulator, Electrical, Evoked Response2decisions
  • OMAAmplitude-Integrated Electroencephalograph1decision
  • IKNElectromyograph, Diagnostic1decision
  • OLTNon-Normalizing Quantitative Electroencephalograph Software1decision
  • OLZAutomatic Event Detection Software For Polysomnograph With Electroencephalograph1decision

Also: MNR (1), OLV (1), GXY (1).

How long do its 510(k) reviews take?

Since 2016, its 8 510(k)s took a median of 146 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 177 days; 4 of its 8 were faster than that.

Whose devices does it build on?

Its devices cite 28 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 5 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.

  • K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc. · 20174cite it
  • K162383Cadwell Sierra Summit, Cadwell Sierra AscentCadwell Industries, Inc. · 20172cite it
  • K133355Cadwell Flex Eeg/PSGCadwell Industries, Inc. · 20141cites it
  • K161027Cadwell AmpliScanCadwell Industries, Inc. · 20161cites it
  • K180269Cadwell Apollo SystemCadwell Industries, Inc. · 20181cites it
  • K201819Cadwell Apollo SystemCadwell Industries, Inc. · 20201cites it

What has FDA decided for it lately?

  • K261442Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayCadwell Industries, Inc. · 2026
  • K250851Hypnos (369054-200)Cadwell Industries, Inc. · 2025
  • K242424Bluebird Single-Use Respiratory Effort BeltCadwell Industries, Inc. · 2024
  • K230415Cadwell GuardianCadwell Industries, Inc. · 2023
  • K201819Cadwell Apollo SystemCadwell Industries, Inc. · 2020
  • K192624ApneaTrakCadwell Industries, Inc. · 2020
  • K190760Cadwell Bolt SoftwareCadwell Industries, Inc. · 2019
  • K181466Cadwell Zenith SystemCadwell Industries, Inc. · 2018

All 13 as Cadwell Industries, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K162199Brand Name: IOMAX Product Name: IOMAX Cortical Module Model/Catalog Number: 190296-200…Aug 18, 2026Class II
  • K162199Cascade IOMAX Cortical Module, REF: 190296-200May 17, 2024Class II
  • K162199Cascade IOMAX Cortical Module, REF: 190296-200Apr 23, 2024Class II

Other applicant names beginning “Cadwell”

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

Cadwell Laboratories, Inc. 46Cadwell 2Cadwell Lab, Inc. 1