510(k) · Cleared
ClearedCaphosol Artificial Saliva
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inpharma A.S. · LFD Saliva, Artificial
Cleared on Aug 10, 1999 as substantially equivalent to K874106 (Fresenius USA, Inc., 1988) after a 62-day review. Its family tree reaches back 1 generation to 1988. 27 later devices descend from it.
- Decided
- Aug 10, 1999
- Review
- 62 days
- Class
- Class U
- Product code
- LFD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K874106 (1988). 27 later devices descend from it, 8 citing it directly.
- Root · 1 generation backK874106 Glandosane (Salivart) Synthetic SalivaFresenius USA, Inc. · 1988
- This deviceK991938 Caphosol Artificial SalivaInpharma A.S. · 1999
- Descendant · cites it directly · 22 of its ownK030802 CaphosolInpharma A.S. · 2003
- Descendant · cites it directly · 19 of its ownK024148 Salinum, OrclairSinclair Pharmaceuticals, Ltd. · 2003
- Descendant · 2 generations on · 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
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K030802CaphosolInpharma A.S. · 2003 · cites it directly22descendants
- K024148Salinum, OrclairSinclair Pharmaceuticals, Ltd. · 2003 · cites it directly19descendants
- K051812Tgo SprayLaboratoires Carilene S.A.S. · 2005 · 2 generations on16descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K874106 | Glandosane (Salivart) Synthetic Saliva | Fresenius USA, Inc. | 1988 | — |
| 0 (this device) | K991938 | Caphosol Artificial Saliva | Inpharma A.S. | 1999 | — |
| +1 | K030802 | Caphosol | Inpharma A.S. | 2003 | — |
| +1 | K024148 | Salinum, Orclair | Sinclair Pharmaceuticals, Ltd. | 2003 | — |
| +2 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2021 | 1 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K874106 | Glandosane (Salivart) Synthetic SalivaSummary page 1…ion and Caphosol™ B — 15 mL Calcium Solution | Classification N Artificial Saliva L Br_cdiga&g Dgyices GLANDOSANE (SALIVART®), Synthetic Saliva, 510(k) Notification K874106, e o decision date April 15, 1988, applicant was Fresenius, USA, Inc., currently distributed by Gebauer Company, Cleveland, Ohio… | 1988 |
What descends from it? (27)
See all 278 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K030802 (Inpharma A.S., 2003) has gone furthest, with 22 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?
Caphosol is indicated for dryness of the mouth or throat (hyposalivation, xerostomia), regardless of the cause and regardless of whether the condition is temporary or permanent. Caphosol is indicated for relief of dryness of the oral mucosa when hyposalivation results from the following: surgery, radiotherapy near the salivary glands, chemotherapy; infection or dysfunction of the salivary glands; inflammation of the mouth or throat; fever; emotional…
Read the full statement (148 words)
Caphosol is indicated for dryness of the mouth or throat (hyposalivation, xerostomia), regardless of the cause and regardless of whether the condition is temporary or permanent.
Caphosol is indicated for relief of dryness of the oral mucosa when hyposalivation results from the following: surgery, radiotherapy near the salivary glands, chemotherapy; infection or dysfunction of the salivary glands; inflammation of the mouth or throat; fever; emotional factors such as fear or anxiety; obstruction of the salivary ducts; Sjogren’s syndrome; and Bell’s Palsy.
Caphosol is also indicated for dryness of the oral mucosa due to drugs such as antihistamines or atropine or other anticholinergic agents that suppress salivary secretion.
It may be used as part of an oral hygiene program for patients with dry mouth. Caphosol provides intensive hygiene of the oral cavity, and may be used to help relieve bad taste and to relieve offensive nasal discharge and crusting.
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/K991938 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991938: Caphosol Artificial Saliva.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991938
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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