510(k) · Cleared
ClearedKilowin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cadwell Laboratories, Inc. · GWE Stimulator, Photic, Evoked Response
Cleared on Jun 11, 1998 after a 435-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Jun 11, 1998
- Review
- 435 days
- Class
- Class II
- Product code
- GWE
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK971214 KilowinCadwell Laboratories, Inc. · 1998
- Descendant · cites it directly · 3 of its ownK133355 Cadwell Flex Eeg/PSGCadwell Industries, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK180269 Cadwell Apollo SystemCadwell Industries, Inc. · 2018
- Descendant · 3 generations on · 1 of its ownK201819 Cadwell Apollo SystemCadwell Industries, Inc. · 2020
- Descendant · 4 generations on · 0 of its ownK221959 Q21Neurofield, Inc. · 2023
Most influential descendants
Showing 4 of 4 · See all- K133355Cadwell Flex Eeg/PSGCadwell Industries, Inc. · 2014 · cites it directly3descendants
- K180269Cadwell Apollo SystemCadwell Industries, Inc. · 2018 · 2 generations on2descendants
- K201819Cadwell Apollo SystemCadwell Industries, Inc. · 2020 · 3 generations on1descendant
- K221959Q21Neurofield, Inc. · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971214 | Kilowin | Cadwell Laboratories, Inc. | 1998 | — |
| +1 | K133355 | Cadwell Flex Eeg/PSG | Cadwell Industries, Inc. | 2014 | — |
| +2 | K180269 | Cadwell Apollo System | Cadwell Industries, Inc. | 2018 | — |
| +3 | K201819 | Cadwell Apollo System | Cadwell Industries, Inc. | 2020 | — |
| +4 | K221959 | Q21 | Neurofield, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GWE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GWE device
- #1 K211643 Vision Monitor - MonpackONEscore 5.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133355 | Cadwell Flex Eeg/PSG | 2014 | 3 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K133355 (Cadwell Industries, Inc., 2014) has gone furthest, with 3 descendants of its own.
How does its category compare?
All GWE devicesGWE Stimulator, Photic, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GWE
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · GWE
Too few GWE 510(k)s in any year since 2007 to give a median.
Recalls per year · GWE
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWE
1in 2025
MAUDE reports naming product code GWE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 1 | — | 1 | 0 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Kilowin is an electroneurodiagnostic device designed to measure and display the electrical signals generated by peripheral nerve, muscle and central nervous system. It will acquire the data necessary for electroencephalography (EEG), electronystagmography (ENG), electrocardiography (ECG), electromyography (EMG), nerve conduction velocity (NCV, F wave, and H reflex), evoked potentials (EP, brainstem, visual, somatosensory), repetitive nerve stimulation…
Read the full statement (133 words)
Kilowin is an electroneurodiagnostic device designed to measure and display the electrical signals generated by peripheral nerve, muscle and central nervous system. It will acquire the data necessary for electroencephalography (EEG), electronystagmography (ENG), electrocardiography (ECG), electromyography (EMG), nerve conduction velocity (NCV, F wave, and H reflex), evoked potentials (EP, brainstem, visual, somatosensory), repetitive nerve stimulation and sleep assessment.
The Kilowin instrument is designed for use during the duration of the procedure only.
Use of the proposed device is to be administered under the direction of a2 trained physician, surgeon, neurologist, or electrophysiologist in an operating room or clinic.
The Kilowin device(s) are intended for use during efectroencephalography (EEG), electronystagmography (ENG), electromyography (EMG), nerve conduction velocity (NCV, F wave, and H reflex), evoked potentials (brainstem, visual, somatosensory), repetitive nerve stimulation testing and sleep assessment.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971214 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971214: Kilowin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971214
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026