510(k) · Cleared
Recalled · Class II · 2025Caphosol® Artifical Saliva (32 doses sachet box)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eusa Pharma (Uk) Limited · LFD Saliva, Artificial
Cleared on Mar 11, 2024 as substantially equivalent to K030802 (Inpharma A.S., 2003) after an 83-day review. Its family tree reaches back 3 generations to 1988. It has been recalled once.
- Decided
- Mar 11, 2024
- Review
- 83 days
- Class
- Class U
- Product code
- LFD
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K874106 (1988). No later device cites it as a predicate yet.
- Root · 3 generations backK874106 Glandosane (Salivart) Synthetic SalivaFresenius USA, Inc. · 1988
- 2 generations backK991938 Caphosol Artificial SalivaInpharma A.S. · 1999
- 1 generation backK030802 CaphosolInpharma A.S. · 2003
- This deviceK234015 Caphosol® Artifical Saliva (32 doses sachet box)Eusa Pharma (Uk) Limited · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K874106 | Glandosane (Salivart) Synthetic Saliva | Fresenius USA, Inc. | 1988 | — |
| −2 | K991938 | Caphosol Artificial Saliva | Inpharma A.S. | 1999 | — |
| −1 | K030802 | Caphosol | Inpharma A.S. | 2003 | — |
| 0 (this device) | K234015 | Caphosol® Artifical Saliva (32 doses sachet box) | Eusa Pharma (Uk) Limited | 2024 | — |
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 |
|---|---|---|---|
| * | K030802 | CaphosolSummary page 6…being in the shelf life package testing protocol needing to change slightly to be for a flexible package rather than a rigid one. Predicate Device: Caphosol® (in vials) K030802 Substantial Equivalence: Caphosol® has not changed its composition or indications for use. The only difference between the subj… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 11, 2025 | Class II | Z-2012-2025 | Device Design | Out of specification stability test result for the Caphosol B solution from process validation lots |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 36 years and passes through 3 companies; a new generation was cleared every 11.3 years on median.
- None of the 3 ancestors has a recall.
- 6 other devices also cite its predicate K030802.
How does its category compare?
All LFD devicesLFD Saliva, Artificial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
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 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 (190 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 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; 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/K234015 · printed Nov 4, 2026
Cite this page
510(k) Report. “K234015: Caphosol® Artifical Saliva (32 doses sachet box).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K234015
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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