510(k) · Cleared
ClearedTrueTear Intranasal Tear Neurostimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allergan · QBR Intranasal Electrostimulation Device For Dry Eye Symptoms
Cleared on Aug 31, 2020 as substantially equivalent to DEN170086 (Allergan, 2018) after a 252-day review. Its family tree reaches back 1 generation to 2018.
- Decided
- Aug 31, 2020
- Review
- 252 days
- Class
- Class II
- Product code
- QBR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN170086 (2018). No later device cites it as a predicate yet.
- Root · 1 generation backDEN170086 TrueTear Intranasal Tear NeurostimulatorAllergan · 2018
- This deviceK193589 TrueTear Intranasal Tear NeurostimulatorAllergan · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN170086 | TrueTear Intranasal Tear Neurostimulator | Allergan | 2018 | — |
| 0 (this device) | K193589 | TrueTear Intranasal Tear Neurostimulator | Allergan | 2020 | — |
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 QBR? 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 |
|---|---|---|---|
| * | DEN170086 | TrueTear Intranasal Tear NeurostimulatorSummary page 4…1 CFR 886.5310) Device Class: Class II Device Product Code: QBR III. PREDICATE DEVICE Allergan TrueTear Intranasal Tear Neurostimulator (DEN170086) IV. DEVICE DESCRIPTION The TrueTear device is a prescription only, non-implantable, electrostimulation device intended to i… | 2018 |
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 QBR devicesQBR Intranasal Electrostimulation Device For Dry Eye Symptoms: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · QBR
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · QBR
Too few QBR 510(k)s in any year since 2007 to give a median.
Recalls per year · QBR
No recall names QBR since 2007.
Adverse event reports per year · QBR
No MAUDE report names QBR 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 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 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 TrueTear Intranasal Tear Neurostimulator provides a temporary increase in tear production during neurostimulation to improve dry eye symptoms in adult patients with severe dry eye symptoms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193589 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193589: TrueTear Intranasal Tear Neurostimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193589
Report an extraction error
Are you the manufacturer?
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