510(k) · Cleared
ClearedSmartMouth DryMouth Oral Rinse
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Triumph Pharmaceuticals, Inc. · LFD Saliva, Artificial
Cleared on Feb 15, 2019 as substantially equivalent to K123731 (Glaxosmithkline Consumer Healthcare (Gskch), 2013) and 1 other predicate after a 287-day review. Its family tree reaches back 2 generations to 2013.
- Decided
- Feb 15, 2019
- Review
- 287 days
- Class
- Class U
- Product code
- LFD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K123731 (2013). No later device cites it as a predicate yet.
- Root · 2 generations backK123731 Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, Biotene…Glaxosmithkline Consumer Healthcare (Gskch) · 2013 · Recalled
- 1 generation backK163029 Hydris™ Oral RinseBiopharm Consult, LLC · 2017
- This deviceK181194 SmartMouth DryMouth Oral RinseTriumph Pharmaceuticals, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K123731 | Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, Biotene Moisturizing… | Glaxosmithkline Consumer Healthcare (Gskch) | 2013 | 1 |
| −1 | K163029 | Hydris™ Oral Rinse | Biopharm Consult, LLC | 2017 | — |
| 0 (this device) | K181194 | SmartMouth DryMouth Oral Rinse | Triumph Pharmaceuticals, 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 LFD? 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 LFD device
- #1 K253778 Allday Moisturizing Rinsescore 11.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K123731 | Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, Biotene Moisturizing Mouth SpraySummary page 5…Biotene Dry Mouth Oral Rinse (Primary Predicate Device) 501(k) Number K123731 Name Hyrdris Oral Rinse (Reference Pred… | 2013 |
| * | K163029 | Hydris™ Oral RinseSummary page 5…Hyrdris Oral Rinse (Reference Predicate Device) 501(k) Number K163029 Technological characteristics and comparison SmartMouth® DryMouth Oral Rinse is substantially equivalent to Biotene Dry Mouth… | 2017 |
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 6 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 8 other devices also cite its predicate K123731.
How does its category compare?
All LFD devicesLFD Saliva, Artificial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · LFD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LFD
287in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LFD
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFD
11in 2025
MAUDE reports naming product code LFD, 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 | 2 | — | 1 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 3 | 83 | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 3 | 209 | 0 | 5 |
| 2012 | 2 | — | 0 | 7 |
| 2013 | 2 | — | 1 | 37 |
| 2014 | 0 | — | 0 | 19 |
| 2015 | 5 | 156 | 0 | 28 |
| 2016 | 0 | — | 0 | 68 |
| 2017 | 3 | 231 | 0 | 51 |
| 2018 | 5 | 210 | 0 | 37 |
| 2019 | 3 | 287 | 0 | 40 |
| 2020 | 1 | — | 0 | 34 |
| 2021 | 2 | — | 0 | 30 |
| 2022 | 0 | — | 0 | 15 |
| 2023 | 1 | — | 0 | 10 |
| 2024 | 2 | — | 0 | 14 |
| 2025 | 1 | — | 0 | 11 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Provides relief of the symptoms and discomfort of dry mouth; refreshes, moisturizes, cleans, soothes oral irritation and lubricates oral dryness. Freshens breath.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181194 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181194: SmartMouth DryMouth Oral Rinse.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181194
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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