510(k) · Cleared
ClearedVoutia™
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jeffrey Ward Cash, Dds · LFD Saliva, Artificial
Cleared on Jul 27, 2018 as substantially equivalent to K110116 (Lorin Technologies Corporation, 2011) after a 224-day review. Its family tree reaches back 5 generations to 1988.
- Decided
- Jul 27, 2018
- Review
- 224 days
- Class
- Class U
- Product code
- LFD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K874106 (1988). 11 ancestors in all, the oldest K810157 (1981). No later device cites it as a predicate yet.
- Root · 5 generations backK874106 Glandosane (Salivart) Synthetic SalivaFresenius USA, Inc. · 1988
- 4 generations backK991938 Caphosol Artificial SalivaInpharma A.S. · 1999
- 3 generations backK024148 Salinum, OrclairSinclair Pharmaceuticals, Ltd. · 2003
- 2 generations backK051812 Tgo SprayLaboratoires Carilene S.A.S. · 2005
- 1 generation backK110116 Xeros Dry Mouth PumpLorin Technologies Corporation · 2011
- This deviceK173808 Voutia™Jeffrey Ward Cash, Dds · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K874106 | Glandosane (Salivart) Synthetic Saliva | Fresenius USA, Inc. | 1988 | — |
| −4 | K991938 | Caphosol Artificial Saliva | Inpharma A.S. | 1999 | — |
| −3 | K024148 | Salinum, Orclair | Sinclair Pharmaceuticals, Ltd. | 2003 | — |
| −2 | K051812 | Tgo Spray | Laboratoires Carilene S.A.S. | 2005 | — |
| −1 | K110116 | Xeros Dry Mouth Pump | Lorin Technologies Corporation | 2011 | — |
| 0 (this device) | K173808 | Voutia™ | Jeffrey Ward Cash, Dds | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K110116 | Xeros Dry Mouth PumpSummary page 4…LFD, Unclassified Predicate Device Xeros Dry Mouth Pump Lorin Technologies Corporation K110116 Device Description Voutia™ is a non-sterile, single person use device… | 2011 |
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 30 years and passes through 6 companies; a new generation was cleared every 5.5 years on median.
- 1 of the 11 ancestors has a recall of any class.
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?
The Voutia™ system is indicated to provide relief of dry mouth by coating, moistening, and lubricating oral structures
thereby relieving the symptoms of xerostomia (dry mouth).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173808 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173808: Voutia™.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173808
Report an extraction error
Are you the manufacturer?
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