# K191700: EyeStat

- Pathway: 510(k) (Traditional)
- Applicant: Blinktbi, Inc.
- Decided: Dec 9, 2019 after 167 days
- Product code: GZP (Stimulator, Mechanical, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K950208 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120397: Meb-2300A Neuropack Evoked Potential and Emg Measuring System, Nihon Kohden Corp. (2012) Summary page 4.

## Indications for use
The EyeStat is intended to measure and display the mechanically induced blink reflex. The device is intended to be used by medical personnel within a hospital, laboratory, clinic or nursing home setting or outside of a medical facility under the direct supervision of a medical professional. The device is available for use on any patient as determined by the medical professional including adults and children.

Source page: https://510kreport.com/device/K191700
Methodology: https://510kreport.com/methodology