510(k) · Cleared
ClearedSlivasure
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scandinavian Formulas, Inc. · LED Stains, Chemical Solution
Cleared on Aug 8, 2005 after a 69-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Aug 8, 2005
- Review
- 69 days
- Class
- Class I
- Product code
- LED
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK051409 SlivasureScandinavian Formulas, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK122663 OramoistQuantum, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K122663OramoistQuantum, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051409 | Slivasure | Scandinavian Formulas, Inc. | 2005 | — |
| +1 | K122663 | Oramoist | Quantum, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LED? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K122663 | Oramoist | 2013 | 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?
- Of its descendants, K122663 (Quantum, Inc., 2013) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LED devicesLED Stains, Chemical Solution: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LED
FDA has decided no LED device since 2007.
Median 510(k) review, days · LED
Too few LED 510(k)s in any year since 2007 to give a median.
Recalls per year · LED
No recall names LED since 2007.
Adverse event reports per year · LED
5in 2025
MAUDE reports naming product code LED, 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 | 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 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
SalivaSure TM promotes lubrication of oral mucosa that may be dry due to the side effects of medication, chemo or radiotherapy, or as a symptom of Sjogren's Syndrome, or because of oral inflammation. Salivasure m provides temporary relief for xerostomia, dry mouth or damaged salivary function.
The Ova The Coumter labeling indicates that SalivaSureT is suitable for relief from dry mouth.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K051409 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051409: Slivasure.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051409
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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