# DEN140040: Nautilus BrainPulse 1000

- Pathway: De Novo (Direct)
- Applicant: Jan Medical, Inc.
- Decided: Aug 1, 2016 after 587 days
- Product code: POP (Cranial Motion Measurement Device)
- Device class: 2
- Regulation: 21 CFR 882.1630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K170926: BrainPulse 1100 (2017), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/DEN140040
Methodology: https://510kreport.com/methodology