510(k) · Cleared
ClearedXeros Dry Mouth Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lorin Technologies Corporation · LFD Saliva, Artificial
Cleared on Apr 8, 2011 as substantially equivalent to K091419 (The Procter & Gamble Co., 2009) and 1 other predicate after an 84-day review. Its family tree reaches back 4 generations to 1988. 1 later device descends from it.
- Decided
- Apr 8, 2011
- Review
- 84 days
- Class
- Class U
- Product code
- LFD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K874106 (1988). 10 ancestors in all, the oldest K810157 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK874106 Glandosane (Salivart) Synthetic SalivaFresenius USA, Inc. · 1988
- 3 generations backK991938 Caphosol Artificial SalivaInpharma A.S. · 1999
- 2 generations backK024148 Salinum, OrclairSinclair Pharmaceuticals, Ltd. · 2003
- 1 generation backK051812 Tgo SprayLaboratoires Carilene S.A.S. · 2005
- This deviceK110116 Xeros Dry Mouth PumpLorin Technologies Corporation · 2011
- Descendant · cites it directly · 0 of its ownK173808 Voutia™Jeffrey Ward Cash, Dds · 2018
Most influential descendants
Showing 1 of 1 · See all- K173808Voutia™Jeffrey Ward Cash, Dds · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K874106 | Glandosane (Salivart) Synthetic Saliva | Fresenius USA, Inc. | 1988 | — |
| −3 | K991938 | Caphosol Artificial Saliva | Inpharma A.S. | 1999 | — |
| −2 | K024148 | Salinum, Orclair | Sinclair Pharmaceuticals, Ltd. | 2003 | — |
| −1 | K051812 | Tgo Spray | Laboratoires Carilene S.A.S. | 2005 | — |
| 0 (this device) | K110116 | Xeros Dry Mouth Pump | Lorin Technologies Corporation | 2011 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K091419 | Vicks Powershot Dry Throat & Mouth ReliefSummary page 3…H PUMP artificial saliva I Lofin Technologies Corporation TRADITIONAL Submission Date: 01/10/11 vicks powershot dry throat & mouth relief the procter & gamble co. K091419 08/28/2009 tgo spray laboratoires carilene $.a.5. K051812 10/21/2005 ref: http:/fiwww.accessdata.fda gov/scripts/cdrhvcfdac… | 2009 |
| * | K051812 | Tgo SpraySummary page 3…RADITIONAL Submission Date: 01/10/11 vicks powershot dry throat & mouth relief the procter & gamble co. K091419 08/28/2009 tgo spray laboratoires carilene $.a.5. K051812 10/21/2005 ref: http:/fiwww.accessdata.fda gov/scripts/cdrhvcfdacs/cfPMN/pmn cfm 807.92(z)(3) Lorin Technologies Corporation… | 2005 |
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 |
|---|---|---|---|
| K173808 | Voutia™ | 2018 | 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 23 years and passes through 5 companies; a new generation was cleared every 5.5 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K173808 (Jeffrey Ward Cash, Dds, 2018) 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. 2011, 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?
Dry mouth therapy for chronic dry mouth caused by radiation therapy treatment by adding moisture to the mouth for immediate and effective relief
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/K110116 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110116: Xeros Dry Mouth Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110116
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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