# K133355: Cadwell Flex Eeg/PSG

- Pathway: 510(k) (Traditional)
- Applicant: Cadwell Industries, Inc.
- Decided: Jan 29, 2014 after 90 days
- Product code: GWQ (Full-Montage Standard Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K962603 (1997). 18 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093728: BE Micro, Trea, Eb Neuro S.P.A. (2010). Our reading of the summary gave K091728, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “E13 Neuro BE micro Trea”. Summary page 2.
- K971214: Kilowin, Cadwell Laboratories, Inc. (1998) Summary page 1.

## Most influential descendants
- 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
The Cadwell Flex system is indicated for prescription use to acquire, record, transmit and display physiological and environmental data for electroencephalographic (EEG) and polysomnographic (PSG) ambulatory and/or clinical studies of patients of all ages.

Source page: https://510kreport.com/device/K133355
Methodology: https://510kreport.com/methodology