# K961645: MRS-2D

- Pathway: 510(k) (Traditional)
- Applicant: Lexicor Medical Technology, Inc.
- Decided: Oct 31, 1996 after 185 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: 1 generation back to K920038 (1995). 1 ancestor in all.
6 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920038: Neurosearch-4, Lexicor (1995) Summary page 3.

## Most influential descendants
- K990538: Brainmaster 2E Module and Software Biofeedback Device (1999), 5 descendants of its own
- K073557: Eeg Neuroamp, Model CS10137 (2008), 3 descendants of its own
- K122879: EEGER4 Model 4.3 (2013), 1 descendant of its own
- K252923: IASIS i2 Relaxation Neurofeedback System (2026), 0 descendants of its own
- K222101: Prism (2023), 0 descendants of its own

## Indications for use
BioLex is indicated for relaxation training using alpha EEG biofeedback. In the protocol for relaxation training, BioLex provides a visual and/or auditory signal that corresponds to the patient's increase in alpha activity as an indicator of achieving a state of relaxation.

Source page: https://510kreport.com/device/K961645
Methodology: https://510kreport.com/methodology