510(k) · Cleared
ClearedEyeStat
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Blinktbi, Inc. · GZP Stimulator, Mechanical, Evoked Response
Cleared on Dec 9, 2019 as substantially equivalent to K120397 (Nihon Kohden Corp., 2012) after a 167-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Dec 9, 2019
- Review
- 167 days
- Class
- Class II
- Product code
- GZP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K950208 (1995). No later device cites it as a predicate yet.
- Root · 3 generations backK950208 Nihon Kohden Neuropack Sigma Meb-5500A Evoked Response & Emg…Nihon Kohden America, Inc. · 1995
- 2 generations backK991899 Nihon Kohden Meb-2200A Neuropack Evoked Potential & Emg Measuring…Nihon Kohden America, Inc. · 1999 · Recalled
- 1 generation backK120397 Meb-2300A Neuropack Evoked Potential and Emg Measuring SystemNihon Kohden Corp. · 2012
- This deviceK191700 EyeStatBlinktbi, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K950208 | Nihon Kohden Neuropack Sigma Meb-5500A Evoked Response & Emg Measuring System | Nihon Kohden America, Inc. | 1995 | — |
| −2 | K991899 | Nihon Kohden Meb-2200A Neuropack Evoked Potential & Emg Measuring System with… | Nihon Kohden America, Inc. | 1999 | 1 |
| −1 | K120397 | Meb-2300A Neuropack Evoked Potential and Emg Measuring System | Nihon Kohden Corp. | 2012 | — |
| 0 (this device) | K191700 | EyeStat | Blinktbi, Inc. | 2019 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GZP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K120397 | Meb-2300A Neuropack Evoked Potential and Emg Measuring SystemSummary page 4…ZP / 21 CFR 882.1880 Classification: Class II Predicate Device: • Nihon Kohden MEB-2300A Neuropack Evoked Potential and EMG Measuring System (K120397) Reference Device: • American Optical 12415 AO Non-Contact Tonometer (K802419) • Somatosensory Stimulus System (K9136… | 2012 |
| † | K802419 | AO Non-Contact II Tonometer | 1980 |
| † | K913604 | Somatosensory Stimulus System | 1991 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All GZP devicesGZP Stimulator, Mechanical, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · GZP
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · GZP
Too few GZP 510(k)s in any year since 2007 to give a median.
Recalls per year · GZP
No recall names GZP since 2007.
Adverse event reports per year · GZP
1in 2014
MAUDE reports naming product code GZP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K191700 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191700: EyeStat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191700
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026