# DEN190026: iTEAR Neurostimulator

- Pathway: De Novo (Direct)
- Applicant: Olympic Ophthalmics, Inc.
- Decided: May 1, 2020 after 352 days
- Product code: QKV (Electromechanical Tear Stimulator)
- Device class: 2
- Regulation: 21 CFR 886.5305
- 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
- K213623: iTEAR100 Neurostimulator (2022), 0 descendants of its own

## Indications for use
The iTEAR100 Neurostimulator is an electromechanical nerve stimulator device, indicated for temporary use (up to 30 days) to increase acute tear production during vibratory stimulation of the external nasal nerve in adults, under prescription of an eye care provider.

Source page: https://510kreport.com/device/DEN190026
Methodology: https://510kreport.com/methodology