510(k) · Cleared
ClearedBrainPulse 1100
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
Cleared on Apr 28, 2017 as substantially equivalent to DEN140040 (Jan Medical, Inc., 2016) after a 30-day review. Its family tree reaches back 1 generation to 2016.
- Decided
- Apr 28, 2017
- Review
- 30 days
- Class
- Class II
- Product code
- POP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN140040 (2016). No later device cites it as a predicate yet.
- Root · 1 generation backDEN140040 Nautilus BrainPulse 1000Jan Medical, Inc. · 2016
- This deviceK170926 BrainPulse 1100Jan Medical, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN140040 | Nautilus BrainPulse 1000 | Jan Medical, Inc. | 2016 | — |
| 0 (this device) | K170926 | BrainPulse 1100 | Jan Medical, Inc. | 2017 | — |
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 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
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 |
|---|---|---|---|
| * | DEN140040 | Nautilus BrainPulse 1000Summary page 4…650-316-8812 Device: BrainPulse™ 1100 Trade Name: BrainPulse Predicate Device: BrainPulse 1100 (de novo granted under DEN140040) Regulation Number: 21 CFR 882.1630 Product Code: POP Common/Classification Name: Cranial Motion Mea… | 2016 |
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?
- Its one ancestor has no recall.
How does its category compare?
All POP devicesPOP Cranial Motion Measurement Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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/K170926 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170926: BrainPulse 1100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170926
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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