# K971214: Kilowin

- Pathway: 510(k) (Traditional)
- Applicant: Cadwell Laboratories, Inc.
- Decided: Jun 11, 1998 after 435 days
- Product code: GWE (Stimulator, Photic, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K133355: Cadwell Flex Eeg/PSG (2014), 3 descendants of its own
- K180269: Cadwell Apollo System (2018), 2 descendants of its own
- K201819: Cadwell Apollo System (2020), 1 descendant of its own
- K221959: Q21 (2023), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K971214
Methodology: https://510kreport.com/methodology