Cadwell Industries, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Cadwell Industries, Inc.” (first 2014, latest 2026), across 9 product codes in 2 review panels. Median 510(k) review time under this name: 167 days. Since 2017 the median was 167 days, against 160 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 1 | 90 |
| 2015 | 0 | — |
| 2016 | 1 | 210 |
| 2017 | 2 | 198 |
| 2018 | 2 | 128 |
| 2019 | 1 | 243 |
| 2020 | 2 | 120 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 182 |
| 2024 | 1 | 125 |
| 2025 | 1 | 268 |
| 2026 | 1 | 57 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Cadwell Industries, Inc. took a median 167 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 160 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GWQ | Full-Montage Standard Electroencephalograph | 4 | 4 |
| GWF | Stimulator, Electrical, Evoked Response | 2 | 2 |
| GXY | Electrode, Cutaneous | 1 | 1 |
| IKN | Electromyograph, Diagnostic | 1 | 1 |
| MNR | Ventilatory Effort Recorder | 1 | 1 |
| OLT | Non-Normalizing Quantitative Electroencephalograph Software | 1 | 1 |
| OLV | Standard Polysomnograph With Electroencephalograph | 1 | 1 |
| OLZ | Automatic Event Detection Software For Polysomnograph With Electroencephalograph | 1 | 1 |
| OMA | Amplitude-Integrated Electroencephalograph | 1 | 1 |
Review panels
- Neurology (12)
- Anesthesiology (1)
Most recent Cadwell Industries, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261442 | Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array | GXY | 2026-06-26 | 57 |
| K250851 | Hypnos (369054-200) | OLZ | 2025-12-14 | 268 |
| K242424 | Bluebird Single-Use Respiratory Effort Belt | MNR | 2024-12-18 | 125 |
| K230415 | Cadwell Guardian | GWF | 2023-08-17 | 182 |
| K201819 | Cadwell Apollo System | GWQ | 2020-09-29 | 90 |
| K192624 | ApneaTrak | OLV | 2020-02-20 | 150 |
| K190760 | Cadwell Bolt Software | OLT | 2019-11-23 | 243 |
| K181466 | Cadwell Zenith System | GWQ | 2018-09-01 | 89 |
| K180269 | Cadwell Apollo System | GWQ | 2018-07-17 | 167 |
| K162199 | Cascade IOMAX Intraoperative Monitor | GWF | 2017-03-02 | 209 |
3 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 2 initiated in the last five years. Most recent: 2024-05-17.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Cadwell Industries, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02842476: Accuracy Validation of the Cadwell Pulse Oximetry System (Completed, started 2016-06)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Cadwell Laboratories, Inc. (46 510(k)s)
- Cadwell (2 510(k)s)
- Cadwell Lab, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cadwell Industries, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Cadwell Industries, Inc.” (first 2014, latest 2026), across 9 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cadwell Industries, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cadwell Industries, Inc. is 167 days. Since 2017: 167 days, versus 160 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Cadwell Industries, Inc.?
The most frequent FDA product codes under this applicant name are GWQ (Full-Montage Standard Electroencephalograph, 4); GWF (Stimulator, Electrical, Evoked Response, 2); GXY (Electrode, Cutaneous, 1).
Next steps
- See all 13 Cadwell Industries, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GWQ, Cadwell Industries, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.