510(k) · Cleared
ClearedDry Mouth Mouthwash
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dr. Fresh, Inc. · LFD Saliva, Artificial
Cleared on Apr 27, 2012 as substantially equivalent to K101477 (Glaxosmithkline Consumer Healthcare (Gskch), 2010) after a 359-day review. Its family tree reaches back 6 generations to 1988. 2 later devices descend from it.
- Decided
- Apr 27, 2012
- Review
- 359 days
- Class
- Class U
- Product code
- LFD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K874106 (1988). 8 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK874106 Glandosane (Salivart) Synthetic SalivaFresenius USA, Inc. · 1988
- 5 generations backK991938 Caphosol Artificial SalivaInpharma A.S. · 1999
- 4 generations backK024148 Salinum, OrclairSinclair Pharmaceuticals, Ltd. · 2003
- 3 generations backK051812 Tgo SprayLaboratoires Carilene S.A.S. · 2005
- 2 generations backK061331 Oral Balance Liquid/ GelLaclede, Inc. · 2006
- 1 generation backK101477 Biotene Dry Mouth Mouthwash, Biotene PBF Dry Mouth MouthwashGlaxosmithkline Consumer Healthcare (Gskch) · 2010
- This deviceK111250 Dry Mouth MouthwashDr. Fresh, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK173237 Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free…Syendgen, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK171542 TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth LozengesDr. Harold Katz, LLC (Dba Therabreath · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K874106 | Glandosane (Salivart) Synthetic Saliva | Fresenius USA, Inc. | 1988 | — |
| −5 | K991938 | Caphosol Artificial Saliva | Inpharma A.S. | 1999 | — |
| −4 | K024148 | Salinum, Orclair | Sinclair Pharmaceuticals, Ltd. | 2003 | — |
| −3 | K051812 | Tgo Spray | Laboratoires Carilene S.A.S. | 2005 | — |
| −2 | K061331 | Oral Balance Liquid/ Gel | Laclede, Inc. | 2006 | — |
| −1 | K101477 | Biotene Dry Mouth Mouthwash, Biotene PBF Dry Mouth Mouthwash | Glaxosmithkline Consumer Healthcare (Gskch) | 2010 | — |
| 0 (this device) | K111250 | Dry Mouth Mouthwash | Dr. Fresh, Inc. | 2012 | — |
| +1 | K173237 | Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth… | Syendgen, Inc. | 2018 | — |
| +1 | K171542 | TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges | Dr. Harold Katz, LLC (Dba Therabreath | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
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? (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 |
|---|---|---|---|
| * | K101477 | Biotene Dry Mouth Mouthwash, Biotene PBF Dry Mouth MouthwashSummary page 1…al Classification Name: Saliva, Artificial 3. Identification of Equivalence GlaxoSmithKline Consumer Healthcare Biotene Dry Mouth Oral Rinse (K101477) 4. Device Description Dr. Fresh Dry Mouth Mouthwash is a specifically formulated artificial saliva substitute which cont… | 2010 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 7 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K173237 (Syendgen, Inc., 2018) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K101477.
How does its category compare?
All LFD devicesLFD Saliva, Artificial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
Relieves the symptoms of dry mouth, while moisturizing and lubricating oral dryness;
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111250 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111250: Dry Mouth Mouthwash.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111250
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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