510(k) · Cleared
ClearedCaphosol
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 Nov 25, 2003 as substantially equivalent to K991938 (Inpharma A.S., 1999) after a 257-day review. Its family tree reaches back 2 generations to 1988. 22 later devices descend from it.
- Decided
- Nov 25, 2003
- Review
- 257 days
- Class
- Class U
- Product code
- LFD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K874106 (1988). 22 later devices descend from it, 7 citing it directly.
- Root · 2 generations backK874106 Glandosane (Salivart) Synthetic SalivaFresenius USA, Inc. · 1988
- 1 generation backK991938 Caphosol Artificial SalivaInpharma A.S. · 1999
- This deviceK030802 CaphosolInpharma A.S. · 2003
- Descendant · cites it directly · 16 of its ownK051812 Tgo SprayLaboratoires Carilene S.A.S. · 2005
- Descendant · 2 generations on · 13 of its ownK061331 Oral Balance Liquid/ GelLaclede, Inc. · 2006
- Descendant · 3 generations on · 6 of its ownK101477 Biotene Dry Mouth Mouthwash, Biotene PBF Dry Mouth MouthwashGlaxosmithkline Consumer Healthcare (Gskch) · 2010
- Descendant · 2 generations on · 3 of its ownK062653 Mouthkote Oral Moisturizer, Model 50930-098Parnell Pharmaceuticals, Inc. · 2006
- Descendant · 4 generations on · 2 of its ownK111250 Dry Mouth MouthwashDr. Fresh, Inc. · 2012
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K051812Tgo SprayLaboratoires Carilene S.A.S. · 2005 · cites it directly16descendants
- K061331Oral Balance Liquid/ GelLaclede, Inc. · 2006 · 2 generations on13descendants
- K101477Biotene Dry Mouth Mouthwash, Biotene PBF Dry Mouth MouthwashGlaxosmithkline Consumer Healthcare (Gskch) · 2010 · 3 generations on6descendants
- K062653Mouthkote Oral Moisturizer, Model 50930-098Parnell Pharmaceuticals, Inc. · 2006 · 2 generations on3descendants
- K111250Dry Mouth MouthwashDr. Fresh, Inc. · 2012 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K874106 | Glandosane (Salivart) Synthetic Saliva | Fresenius USA, Inc. | 1988 | — |
| −1 | K991938 | Caphosol Artificial Saliva | Inpharma A.S. | 1999 | — |
| 0 (this device) | K030802 | Caphosol | Inpharma A.S. | 2003 | — |
| +1 | K051812 | Tgo Spray | Laboratoires Carilene S.A.S. | 2005 | — |
| +2 | K061331 | Oral Balance Liquid/ Gel | Laclede, Inc. | 2006 | — |
| +3 | K101477 | Biotene Dry Mouth Mouthwash, Biotene PBF Dry Mouth Mouthwash | Glaxosmithkline Consumer Healthcare (Gskch) | 2010 | — |
| +2 | K062653 | Mouthkote Oral Moisturizer, Model 50930-098 | Parnell Pharmaceuticals, Inc. | 2006 | — |
| +4 | K111250 | Dry Mouth Mouthwash | Dr. Fresh, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 | 1 | 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 |
|---|---|---|---|
| * | K991938 | Caphosol Artificial SalivaSummary page 1…osol Artificial Saliva (Additi oiial indication) 5. 'z'dentif?cationof Lcgally Marketed Device Capliosol Artificial Saliva K99 193 8 6 . Device Description Caphosol is an clectrolyto solution resembling Ittiman saliva, designed in part to… | 1999 |
What descends from it? (22)
See all 227 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?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 11.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K051812 (Laboratoires Carilene S.A.S., 2005) has gone furthest, with 16 descendants of its own.
- 7 other devices also cite its predicate K991938.
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 conditions are temporary or permanent. Caphosol is also indicated as an adjunct to standard oral care in treating the mucositis that may be caused by radiation or high dose chemotherapy. Relief of dryness of the oral mucosa in these conditions is associated with an amelioration of pain. Caphosol may be used for…
Read the full statement (191 words)
Caphosol is indicated for dryness of the mouth or throat (hyposalivation, xerostomia), regardless of the cause and regardless of whether the conditions are temporary or permanent. Caphosol is also indicated as an adjunct to standard oral care in treating the mucositis that may be caused by radiation or high dose chemotherapy. Relief of dryness of the oral mucosa in these conditions is associated with an amelioration of pain.
Caphosol may be used 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; Sjögren'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 as stated in the FDA summary.
https://510kreport.com/device/K030802 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030802: Caphosol.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030802
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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