# K222101: Prism

- Pathway: 510(k) (Traditional)
- Applicant: Graymatters Health, Ltd.
- Decided: Mar 17, 2023 after 242 days
- Product code: HCC (Device, Biofeedback)
- Device class: 2
- Regulation: 21 CFR 882.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K001359 (2000). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122879: EEGER4 Model 4.3, Eeg Software, LLC (2013) Summary page 4.
- K180173: Freespira, Palo Alto Health Sciences, Inc. (2018) Summary page 4.

## Indications for use
Prism is a neurofeedback software device intended for relaxation and stress reduction through the use of EEG biofeedback. The device is indicated as an adjunctive treatment of symptoms associated with posttraumatic stress disorder (PTSD), to be used under the direction of a healthcare professional, together with other pharmacological and/or non-pharmacological interventions.

Source page: https://510kreport.com/device/K222101
Methodology: https://510kreport.com/methodology