# K243426: Nurochek-Pro System

- Pathway: 510(k) (Traditional)
- Applicant: Headsafe Mfg Pty, Ltd.
- Decided: Mar 27, 2025 after 143 days
- Product code: PIW (Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid)
- Device class: 2
- Regulation: 21 CFR 882.1450
- 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 K801604 (1980). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231914: Nurochek-II System, Headsafe Mfg Pty, Ltd. (2023) Summary page 5.

## Indications for use
The Nurochek-Pro System is intended for prescription use in healthcare facilities for subjects aged between 12 and 44 years old, for the aid in diagnosis of mild traumatic brain injury (mTBI) in conjunction with a standard neurological assessment. The Nurochek-Pro System is indicated for the generation of visual evoked potentials (VEP) and to acquire, transmit, display, and store electroencephalograms (EEG) during the generation of VEPs. Additionally, the system is indicated to analyze captured EEG signals to provide an aid in the diagnosis of mild traumatic brain injury (mTBI) in subjects aged between 12 and 44 years old who have sustained a potential head injury in the past 120 hours (5 days).

Source page: https://510kreport.com/device/K243426
Methodology: https://510kreport.com/methodology