510(k) · Cleared
Recalled · 2007Salivart Oral Moisturizer Model Number 03866-009-75 Salivart Oral Moisturizer Model Number 0386-000-25
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gebauer Co. · LFD Saliva, Artificial
Cleared on Aug 6, 2001 after a 1,181-day review. The FDA summary names its predicate without a number. 21 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 6, 2001
- Review
- 1,181 days
- Class
- Class U
- Product code
- LFD
- Recalls
- 2
- Predicates
- 0
21 later devices descend from it, 8 citing it directly.
- This deviceK981693 Salivart Oral Moisturizer Model Number 03866-009-75 Salivart Oral…Gebauer Co. · 2001
- Descendant · cites it directly · 19 of its ownK024148 Salinum, OrclairSinclair Pharmaceuticals, Ltd. · 2003
- Descendant · cites it directly · 16 of its ownK051812 Tgo SprayLaboratoires Carilene S.A.S. · 2005
- Descendant · cites it directly · 13 of its ownK061331 Oral Balance Liquid/ GelLaclede, Inc. · 2006
- Descendant · 2 generations on · 6 of its ownK101477 Biotene Dry Mouth Mouthwash, Biotene PBF Dry Mouth MouthwashGlaxosmithkline Consumer Healthcare (Gskch) · 2010
- Descendant · cites it directly · 3 of its ownK062653 Mouthkote Oral Moisturizer, Model 50930-098Parnell Pharmaceuticals, Inc. · 2006
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K024148Salinum, OrclairSinclair Pharmaceuticals, Ltd. · 2003 · cites it directly19descendants
- K051812Tgo SprayLaboratoires Carilene S.A.S. · 2005 · cites it directly16descendants
- K061331Oral Balance Liquid/ GelLaclede, Inc. · 2006 · cites it directly13descendants
- K101477Biotene Dry Mouth Mouthwash, Biotene PBF Dry Mouth MouthwashGlaxosmithkline Consumer Healthcare (Gskch) · 2010 · 2 generations on6descendants
- K062653Mouthkote Oral Moisturizer, Model 50930-098Parnell Pharmaceuticals, Inc. · 2006 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981693 | Salivart Oral Moisturizer Model Number 03866-009-75 Salivart Oral Moisturizer… | Gebauer Co. | 2001 | — |
| +1 | K024148 | Salinum, Orclair | Sinclair Pharmaceuticals, Ltd. | 2003 | — |
| +1 | K051812 | Tgo Spray | Laboratoires Carilene S.A.S. | 2005 | — |
| +1 | K061331 | Oral Balance Liquid/ Gel | Laclede, Inc. | 2006 | — |
| +2 | K101477 | Biotene Dry Mouth Mouthwash, Biotene PBF Dry Mouth Mouthwash | Glaxosmithkline Consumer Healthcare (Gskch) | 2010 | — |
| +1 | K062653 | Mouthkote Oral Moisturizer, Model 50930-098 | Parnell Pharmaceuticals, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2021 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | — | MOI-STIR® Mouth Moistener Named without a submission number |
What descends from it? (21)
See all 218 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K024148 | Salinum, Orclair | 2003 | 19 |
| K051812 | Tgo Spray | 2005 | 16 |
| K061331 | Oral Balance Liquid/ Gel | 2006 | 13 |
| K062653 | Mouthkote Oral Moisturizer, Model 50930-098 | 2006 | 3 |
| K072306 | Bioxtra Moisturizing Gel | 2007 | 2 |
| K023046 | SST Saliva Supporting Tablets | 2002 | 1 |
| K071617 | Oral Neutralizer | 2007 | 0 |
| K041563 | Oasis Dry Mouth Relief Discs or Oasis Mouth Moisturizing Discs | 2004 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 19, 2007 | Not classified | Z-0497-2007 | Other | Microbial Contamination-certain lots of product failed USP <61> Microbial Limits Testing for total aerobic count during 6 month stability testing. |
| Feb 23, 2004 | Not classified | Z-0641-04 | Other | The actuator valve is defective, which may allow the valve to remain open after use and continue to spray until the can is empty. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K024148 (Sinclair Pharmaceuticals, Ltd., 2003) has gone furthest, with 19 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.
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?
An oral moisturizer which temporarily relieves the discomfort of dry mouth (xerostomia) and dry throat naturally. Salivart may be used to replace human saliva, when the amount of saliva normally secreted has been reduced. Salivart lubricates the mouth and throat to soothe discomfort and assist in speaking and swallowing. Salivart relieves dry mouth caused by certain medications, therapeutic treatments, diseases, normal aging and emotional factors.
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/K981693 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981693: Salivart Oral Moisturizer Model Number 03866-009-75 Salivart Oral Moisturizer Model Number 0386-000-25.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981693
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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