510(k) · Cleared

Cleared

Mouthkote Oral Moisturizer, Model 50930-098

K062653510(k) TraditionalCleared Oct 27, 200650-day reviewClass U

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

Parnell Pharmaceuticals, Inc. · LFD Saliva, Artificial

Cleared on Oct 27, 2006 as substantially equivalent to K061331 (Laclede, Inc., 2006) and 4 other predicates after a 50-day review. Its family tree reaches back 5 generations to 1988. 3 later devices descend from it.

Decided: Oct 27, 2006
Review: 50 days
Class: Class U
Product code: LFD
Recalls: None
Predicates: 5

Its longest line of descent runs back 5 generations to K874106 (1988). 7 ancestors in all. 3 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 5 generations backK874106 Glandosane (Salivart) Synthetic SalivaFresenius USA, Inc. · 1988
4 generations backK991938 Caphosol Artificial SalivaInpharma A.S. · 1999
3 generations backK024148 Salinum, OrclairSinclair Pharmaceuticals, Ltd. · 2003
2 generations backK051812 Tgo SprayLaboratoires Carilene S.A.S. · 2005
1 generation backK061331 Oral Balance Liquid/ GelLaclede, Inc. · 2006
This deviceK062653 Mouthkote Oral Moisturizer, Model 50930-098Parnell Pharmaceuticals, Inc. · 2006
Descendant · cites it directly · 2 of its ownK072306 Bioxtra Moisturizing GelBio-X Healthcare S.A. · 2007
Descendant · 2 generations on · 0 of its ownK202689 Dentilube SprayOxy2plus, LLC · 2021
Descendant · 2 generations on · 0 of its ownK101346 GC Oral Moisturizing GelGC America, Inc. · 2011

Most influential descendants

Showing 3 of 3 · See all

K072306Bioxtra Moisturizing GelBio-X Healthcare S.A. · 2007 · cites it directly2descendants
K202689Dentilube SprayOxy2plus, LLC · 2021 · 2 generations on0descendants
K101346GC Oral Moisturizing GelGC America, Inc. · 2011 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K874106	Glandosane (Salivart) Synthetic Saliva	Fresenius USA, Inc.	1988	—
−4	K991938	Caphosol Artificial Saliva	Inpharma A.S.	1999	—
−3	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	—
0 (this device)	K062653	Mouthkote Oral Moisturizer, Model 50930-098	Parnell Pharmaceuticals, Inc.	2006	—
+1	K072306	Bioxtra Moisturizing Gel	Bio-X Healthcare S.A.	2007	—
+2	K202689	Dentilube Spray	Oxy2plus, LLC	2021	—
+2	K101346	GC Oral Moisturizing Gel	GC America, Inc.	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2003	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2011	1	0
2021	1	0

FIG. 1 — Lineage of K062653, 1988–2021Source: 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? (5)

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
*	K061331	Oral Balance Liquid/ Gel Summary page 1 …LFD 4. Devices to which new device is substantially equivalent: 1. Laclede, Inc. Oral Balance cleared in K061331 2. Inpharma AB Caphasol cleared in K991938 3. Gebauer Company…	Laclede, Inc.	2006	—
*	K991938	Caphosol Artificial Saliva Summary page 1 …lly equivalent: 1. Laclede, Inc. Oral Balance cleared in K061331 2. Inpharma AB Caphasol cleared in K991938 3. Gebauer Company Salivart cleared in K981693 4. Sinclair Pharmaceuticals…	Inpharma A.S.	1999	—
*	K981693	Salivart Oral Moisturizer Model Number 03866-009-75 Salivart Oral Moisturizer Model… Summary page 1 …cleared in K061331 2. Inpharma AB Caphasol cleared in K991938 3. Gebauer Company Salivart cleared in K981693 4. Sinclair Pharmaceuticals Salinum/Oraclair cleared in K024148 5. Laboratoires Carilene S.A.S.…	Gebauer Co.	2001	2
*	K024148	Salinum, Orclair Summary page 1 …n K991938 3. Gebauer Company Salivart cleared in K981693 4. Sinclair Pharmaceuticals Salinum/Oraclair cleared in K024148 5. Laboratoires Carilene S.A.S. TGO Spray cleared in K051812 5. Device Description: MouthKote is a…	Sinclair Pharmaceuticals, Ltd.	2003	—
*	K051812	Tgo Spray Summary page 1 …n K981693 4. Sinclair Pharmaceuticals Salinum/Oraclair cleared in K024148 5. Laboratoires Carilene S.A.S. TGO Spray cleared in K051812 5. Device Description: MouthKote is an artificial saliva substitute which contains moisturizers, polysaccharid…	Laboratoires Carilene S.A.S.	2005	—

Also cleared against K061331: 7 other devices →

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K072306	Bioxtra Moisturizing Gel	Bio-X Healthcare S.A.	2007	2

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 18 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
1 of the 7 ancestors has a recall of any class.
Of its descendants, K072306 (Bio-X Healthcare S.A., 2007) has gone furthest, with 2 descendants of its own.
7 other devices also cite its predicate K061331.

How does its category compare?

All LFD devices

LFD Saliva, Artificial: FDA decisions, review times, recalls and adverse event reports over 20 years.

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?

Relieves dry mouth conditions

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K062653 · printed Nov 5, 2026

Cite this page

510(k) Report. “K062653: Mouthkote Oral Moisturizer, Model 50930-098.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062653

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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