510(k) · Cleared
ClearediTEAR100 Neurostimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympic Ophthalmics · QKV Electromechanical Tear Stimulator
Cleared on Mar 16, 2022 as substantially equivalent to DEN190026 (Olympic Ophthalmics, Inc., 2020) after a 120-day review. Its family tree reaches back 1 generation to 2020.
- Decided
- Mar 16, 2022
- Review
- 120 days
- Class
- Class II
- Product code
- QKV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN190026 (2020). No later device cites it as a predicate yet.
- Root · 1 generation backDEN190026 iTEAR NeurostimulatorOlympic Ophthalmics, Inc. · 2020
- This deviceK213623 iTEAR100 NeurostimulatorOlympic Ophthalmics · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN190026 | iTEAR Neurostimulator | Olympic Ophthalmics, Inc. | 2020 | — |
| 0 (this device) | K213623 | iTEAR100 Neurostimulator | Olympic Ophthalmics | 2022 | — |
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 QKV? 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 |
|---|---|---|---|
| * | DEN190026 | iTEAR NeurostimulatorSummary page 4…chanical tear stimulator Regulatory Class: Class II Product Code: QKV Regulation: 21 CFR 886.5305 Predicate Device iTEAR100 Neurostimulator (DEN190026) Device Description The iTEAR100 device is a prescription only, non-implantable, electromechanical stimulator inten… | 2020 |
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?
- Its one ancestor has no recall.
How does its category compare?
All QKV devicesQKV Electromechanical Tear Stimulator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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/K213623 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213623: iTEAR100 Neurostimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213623
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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