510(k) · Cleared
ClearedNurochek-Pro System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Headsafe Mfg Pty, Ltd. · PIW Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid
Cleared on Mar 27, 2025 as substantially equivalent to K231914 (Headsafe Mfg Pty, Ltd., 2023) after a 143-day review. Its family tree reaches back 7 generations to 1980.
- Decided
- Mar 27, 2025
- Review
- 143 days
- Class
- Class II
- Product code
- PIW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K801604 (1980). 23 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK801604 Pathfinder Electrodiagnostic SystemNicolet Biomedical Instruments · 1980
- 6 generations backK974748 Neurometric Analysis SystemNxlink, Ltd. · 1998
- 5 generations backK161068 Ahead 300Brainscope Company, Inc. · 2016
- 4 generations backK181179 BrainScope OneBrainscope Company, Inc. · 2018
- 3 generations backK183241 BrainScope TBI (Model: Ahead 400)Brainscope Company, Inc. · 2019
- 2 generations backK190815 BrainScope TBIBrainscope Company, Inc. · 2019
- 1 generation backK231914 Nurochek-II SystemHeadsafe Mfg Pty, Ltd. · 2023
- This deviceK243426 Nurochek-Pro SystemHeadsafe Mfg Pty, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K801604 | Pathfinder Electrodiagnostic System | Nicolet Biomedical Instruments | 1980 | — |
| −6 | K974748 | Neurometric Analysis System | Nxlink, Ltd. | 1998 | — |
| −5 | K161068 | Ahead 300 | Brainscope Company, Inc. | 2016 | — |
| −4 | K181179 | BrainScope One | Brainscope Company, Inc. | 2018 | — |
| −3 | K183241 | BrainScope TBI (Model: Ahead 400) | Brainscope Company, Inc. | 2019 | — |
| −2 | K190815 | BrainScope TBI | Brainscope Company, Inc. | 2019 | — |
| −1 | K231914 | Nurochek-II System | Headsafe Mfg Pty, Ltd. | 2023 | — |
| 0 (this device) | K243426 | Nurochek-Pro System | Headsafe Mfg Pty, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 3 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 3 | 0 |
| 1995 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PIW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PIW device
- #1 K231914 Nurochek-II Systemscore 11.1 · 6 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K231914 | Nurochek-II SystemSummary page 5…ochek-Pro System is substantially equivalent to the following predicate: 510(k) Number Predicate Device Name / Manufacturer Primary Predicate K231914 Nurochek-II System / Headsafe MFG Pty Ltd. The predicate device has not been subject to a design rel… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 45 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- None of the 23 ancestors has a recall.
How does its category compare?
All PIW devicesPIW Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · PIW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PIW
Too few PIW 510(k)s in any year since 2007 to give a median.
Recalls per year · PIW
No recall names PIW since 2007.
Adverse event reports per year · PIW
No MAUDE report names PIW since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (111 words)
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243426 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243426: Nurochek-Pro System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243426
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026