# DEN140017: Sensimed Triggerfish

- Pathway: De Novo (Direct)
- Applicant: Sensimed AG
- Decided: Mar 4, 2016 after 668 days
- Product code: PLZ (Ocular Pattern Recorder)
- Device class: 2
- Regulation: 21 CFR 886.1925
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The SENSIMED Triggerfish® is a prescription device indicated to detect the peak patterns of variation in intraocular pressure over a maximum period of 24 hours to identify the window of time to measure intraocular pressure by conventional clinical methods. The SENSIMED Triggerfish® is indicated for patients 22 years of age and older.

Source page: https://510kreport.com/device/DEN140017
Methodology: https://510kreport.com/methodology