# K170926: BrainPulse 1100

- Pathway: 510(k) (Special)
- Applicant: Jan Medical, Inc.
- Decided: Apr 28, 2017 after 30 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
Longest line of descent: 1 generation back to DEN140040 (2016). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN140040: Nautilus BrainPulse 1000, Jan Medical, Inc. (2016) Summary page 4.

## 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/K170926
Methodology: https://510kreport.com/methodology