Company ยท US
Cadwell Industries, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2026. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (2 in 12 months)
3recalls (1 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GWF | Stimulator, Electrical, Evoked Response | 5 |
| GWQ | Full-Montage Standard Electroencephalograph | 4 |
| GXY | Electrode, Cutaneous | 1 |
| IKN | Electromyograph, Diagnostic | 1 |
| MNR | Ventilatory Effort Recorder | 1 |
| OLT | Non-Normalizing Quantitative Electroencephalograph Software | 1 |
| OLV | Standard Polysomnograph With Electroencephalograph | 1 |
| OLZ | Automatic Event Detection Software For Polysomnograph With Electroencephalograph | 1 |
| OMA | Amplitude-Integrated Electroencephalograph | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 26, 2026 | K261442 | Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array Cadwell Industries, Inc. | GXY |
| Dec 14, 2025 | K250851 | Hypnos (369054-200) Cadwell Industries, Inc. | OLZ |
| Dec 18, 2024 | K242424 | Bluebird Single-Use Respiratory Effort Belt Cadwell Industries, Inc. | MNR |
| Aug 17, 2023 | K230415 | Cadwell Guardian Cadwell Industries, Inc. | GWF |
| Sep 29, 2020 | K201819 | Cadwell Apollo System Cadwell Industries, Inc. | GWQ |
| Feb 20, 2020 | K192624 | ApneaTrak Cadwell Industries, Inc. | OLV |
| Nov 23, 2019 | K190760 | Cadwell Bolt Software Cadwell Industries, Inc. | OLT |
| Sep 1, 2018 | K181466 | Cadwell Zenith System Cadwell Industries, Inc. | GWQ |
| Jul 17, 2018 | K180269 | Cadwell Apollo System Cadwell Industries, Inc. | GWQ |
| Mar 2, 2017 | K162199 | Cascade IOMAX Intraoperative Monitor Cadwell Industries, Inc. | GWF |
| Mar 1, 2017 | K162383 | Cadwell Sierra Summit, Cadwell Sierra Ascent Cadwell Industries, Inc. | IKN |
| Nov 8, 2016 | K161027 | Cadwell AmpliScan Cadwell Industries, Inc. | OMA |
| Jan 29, 2014 | K133355 | CADWELL FLEX EEG/PSG Cadwell Industries, Inc. | GWQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 9, 2026 | Cadwell Industries Inc Brand Name: IOMAX
Product Name: IOMAX Cortical Module
Model/Catalog Number: 190296-200
UDI-DI code: 00840067100653
Product Description: The IOMAX Cortical Module contains a 16-channel amplifier, a low Open, Classified |
GWF | K162199 |
| Jul 12, 2024 | Cadwell Industries Inc Cascade IOMAX Cortical Module, REF: 190296-200 Open, Classified |
GWF | K162199 |
| May 22, 2024 | Cadwell Industries Inc Cascade IOMAX Cortical Module, REF: 190296-200 Open, Classified |
GWF | K162199 |