510(k) · Cleared
ClearedSalivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Laclede, Inc. · LFD Saliva, Artificial
Cleared on Oct 11, 2018 as substantially equivalent to K103745 (Glaxosmithkline Consumer Healthcare (Gskch), 2011) and 1 other predicate after a 210-day review. Its family tree reaches back 6 generations to 1988. 1 later device descends from it.
- Decided
- Oct 11, 2018
- Review
- 210 days
- Class
- Class U
- Product code
- LFD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K874106 (1988). 9 ancestors in all. 1 later device descends from it, 1 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 deviceK180680 Salivea Dry Mouth Mouthwash, Salivea Dry Mouth MouthsprayLaclede, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK240508 Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)Laclede, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K240508Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)Laclede, Inc. · 2024 · cites it directly0descendants
View 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) | K180680 | Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray | Laclede, Inc. | 2018 | — |
| +1 | K240508 | Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel) | Laclede, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 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? (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 |
|---|---|---|---|
| * | K103745 | Biotene Moisturizing Mouth Spray for Dry Mouth Symptom ReliefSummary page 4…TH MOUTHSPRAY Regulation Number: Unclassified Regulation Name: Saliva, Artificial Product Code: LFD Primary Predicate Device: BIOTENE MOISTURIZING MOUTHSPRAY, GSKCH, K103745 BIOTENE DRY MOUTH MOUTHWASH, GSKCH, K101477 Reference Predicate Device: Oral 7 Moisturizing Spray and Mouthwash, J.C.E.C Company… | 2011 |
| * | K101477 | Biotene Dry Mouth Mouthwash, Biotene PBF Dry Mouth MouthwashSummary page 4…ed Regulation Name: Saliva, Artificial Product Code: LFD Primary Predicate Device: BIOTENE MOISTURIZING MOUTHSPRAY, GSKCH, K103745 BIOTENE DRY MOUTH MOUTHWASH, GSKCH, K101477 Reference Predicate Device: Oral 7 Moisturizing Spray and Mouthwash, J.C.E.C Company Inc., K142549 Oral Balance Gel, Laclede, In… | 2010 |
| † | K142549 | Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mouth Spray… | 2015 |
| † | K061331 | Oral Balance Liquid/ Gel | 2006 |
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 |
|---|---|---|---|
| K240508 | Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel) | 2024 | 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?
- The line of descent spans 30 years and passes through 6 companies; a new generation was cleared every 4.2 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K240508 (Laclede, Inc., 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LFD devicesLFD Saliva, Artificial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
Relieve symptoms of dry mouth, refresh, moisturize, clean and sooth oral irritation, and oral dryness.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K180680 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180680: Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180680
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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