# K252923: IASIS i2 Relaxation Neurofeedback System

- Pathway: 510(k) (Traditional)
- Applicant: Iasis Technologies
- Decided: Mar 13, 2026 after 179 days
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K920038 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945826: J & J I-330 Series Physiological Monitoring & Biofeedback Instument and Use Software Applications, Medical Device Inspection Co., Inc. (1995) Summary page 6.
- K990538: Brainmaster 2E Module and Software Biofeedback Device, Brainmaster (1999) Summary page 6.

## Indications for use
IASIS i2 Relaxation Neurofeedback System is a neurofeedback device intended for relaxation and stress reduction through the use of EEG biofeedback.

Source page: https://510kreport.com/device/K252923
Methodology: https://510kreport.com/methodology