# K212788: Seer Home

- Pathway: 510(k) (Traditional)
- Applicant: Seer Medical Pty, Ltd.
- Decided: Jun 16, 2022 after 288 days
- Product code: GWQ (Full-Montage Standard Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K001564 (2000). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170441: ElectroTek, Mobilemedtek (2017) Summary page 4.

## Recalls of this device
- Aug 12, 2024 · Class II · Z-3143-2024: During CAPA investigations of sight production inconsistencies, it was highlighted that previous Electromagnetic Compatibility (EMC) assessments related to RF radiated emissions may not be reasonably 

## Indications for use
The electroencephalographic system Seer Home is intended to acquire, display, and store the electro-physiological signals of the patient's brain obtained by placing electrodes on the patient scalp. The Seer Home is intended to be used for such studies as electroencephalograph (EEG) and video EEG recording to aid in diagnosis of neurological disorders. The Seer Home does not draw any diagnostic conclusions. Seer Home is not intended for use as life support equipment such as vital signs monitoring in intensive care units. Seer Home is only to be used under the direction and supervision of a physician or EEG technologist or clinician.

Source page: https://510kreport.com/device/K212788
Methodology: https://510kreport.com/methodology