De Novo · Granted
GrantedNautilus BrainPulse 1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jan Medical, Inc. · POP Cranial Motion Measurement Device
Granted on Aug 1, 2016 as a new device type through De Novo after a 587-day review. 1 later device descends from it.
- Decided
- Aug 1, 2016
- Review
- 587 days
- Class
- Class II
- Product code
- POP
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceDEN140040 Nautilus BrainPulse 1000Jan Medical, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK170926 BrainPulse 1100Jan Medical, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K170926BrainPulse 1100Jan Medical, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN140040 | Nautilus BrainPulse 1000 | Jan Medical, Inc. | 2016 | — |
| +1 | K170926 | BrainPulse 1100 | Jan Medical, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
Sources: FDA De Novo 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 POP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170926 | BrainPulse 1100 | 2017 | 0 |
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?
- Of its descendants, K170926 (Jan Medical, Inc., 2017) has gone furthest, with 0 descendants of its own.
How does its category compare?
All POP devicesPOP Cranial Motion Measurement Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · POP
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · POP
Too few POP 510(k)s in any year since 2007 to give a median.
Recalls per year · POP
No recall names POP since 2007.
Adverse event reports per year · POP
No MAUDE report names POP 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 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The BrainPulse is intended for use on a patient’s head to non-invasively detect, amplify and capture the skull motion caused by pulsatile flow from the cardiac cycle. The BrainPulse is not indicated to aid in the diagnosis of neurological conditions, diseases, or disorders.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN140040 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN140040: Nautilus BrainPulse 1000.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN140040
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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