De Novo · Granted
GrantediTEAR Neurostimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympic Ophthalmics, Inc. · QKV Electromechanical Tear Stimulator
Granted on May 1, 2020 as a new device type through De Novo after a 352-day review. 1 later device descends from it.
- Decided
- May 1, 2020
- Review
- 352 days
- Class
- Class II
- Product code
- QKV
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceDEN190026 iTEAR NeurostimulatorOlympic Ophthalmics, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK213623 iTEAR100 NeurostimulatorOlympic Ophthalmics · 2022
Most influential descendants
Showing 1 of 1 · See all- K213623iTEAR100 NeurostimulatorOlympic Ophthalmics · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN190026 | iTEAR Neurostimulator | Olympic Ophthalmics, Inc. | 2020 | — |
| +1 | K213623 | iTEAR100 Neurostimulator | Olympic Ophthalmics | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
Sources: FDA De Novo 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 QKV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QKV device
- #1 K213623 iTEAR100 Neurostimulatorscore 3.0 · 1 generation · no Class I recall
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213623 | iTEAR100 Neurostimulator | 2022 | 0 |
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?
- Of its descendants, K213623 (Olympic Ophthalmics, 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QKV devicesQKV Electromechanical Tear Stimulator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · QKV
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · QKV
Too few QKV 510(k)s in any year since 2007 to give a median.
Recalls per year · QKV
No recall names QKV since 2007.
Adverse event reports per year · QKV
No MAUDE report names QKV since 2007.
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 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN190026 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN190026: iTEAR Neurostimulator.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN190026
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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