510(k) · Cleared

Cleared

Caphosol Artifical Saliva Tablets

K162167510(k) TraditionalCleared Mar 31, 2017240-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Eusa Pharma (Uk) Limited · LFD Saliva, Artificial

Cleared on Mar 31, 2017 as substantially equivalent to K030802 (Inpharma A.S., 2003) after a 240-day review. Its family tree reaches back 3 generations to 1988.

Decided: Mar 31, 2017
Review: 240 days
Class: Class U
Product code: LFD
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K874106 (1988). No later device cites it as a predicate yet.

By dateBy generation

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 deviceK162167 Caphosol Artifical Saliva TabletsEusa Pharma (Uk) Limited · 2017

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)	K162167	Caphosol Artifical Saliva Tablets	Eusa Pharma (Uk) Limited	2017	—

FIG. 1 — Lineage of K162167, 1988–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K030802	Caphosol Summary page 4 …Proprietary Name: Caphosol Artificial Saliva Regulation Number: Unclassified Product Code: LFD Predicate Devices: K030802 Primary Description of the device and its intended application: Caphosol is a supersaturated calcium phosphate, electrolyte m…	Inpharma A.S.	2003	—

Also cleared against K030802: 6 other devices →

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 29 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 devices

LFD Saliva, Artificial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · LFD

1in 2025

2007high 5 (2015) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LFD

287in 2019

2007high 287 (2019) · low 83 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LFD

1in 2013

2007high 1 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LFD

11in 2025

2007high 68 (2016) · low 0 (2008)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 Dispersible is indicated for dryness of the mouth and throat (hyposalivation, xerostomia), regardless of the cause and regardless of whether the condition is temporary or permanent. Caphosol Dispersible is also indicated as an adjunct to standard oral care in the treatment of 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 amelioration of pain.

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/K162167 · printed Nov 6, 2026

Cite this page

510(k) Report. “K162167: Caphosol Artifical Saliva Tablets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162167

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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