510(k) · Cleared

Cleared

Allday Moisturizing Rinse

K253778510(k) TraditionalCleared Feb 27, 202693-day reviewClass U

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

Elevate Oral Care · LFD Saliva, Artificial

Cleared on Feb 27, 2026 as substantially equivalent to K150074 (Elevate Oral Care, 2015) after a 93-day review. Its family tree reaches back 2 generations to 2013.

Decided: Feb 27, 2026
Review: 93 days
Class: Class U
Product code: LFD
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K123731 (2013). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK123731 Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, Biotene…Glaxosmithkline Consumer Healthcare (Gskch) · 2013 · Recalled
1 generation backK150074 Elevate Moisturizing SprayElevate Oral Care · 2015
This deviceK253778 Allday Moisturizing RinseElevate Oral Care · 2026

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K123731	Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, Biotene Moisturizing…	Glaxosmithkline Consumer Healthcare (Gskch)	2013	1
−1	K150074	Elevate Moisturizing Spray	Elevate Oral Care	2015	—
0 (this device)	K253778	Allday Moisturizing Rinse	Elevate Oral Care	2026	—

FIG. 1 — Lineage of K253778, 2013–2026Source: 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 K250390 CloSYS® Dry Mouth Sensitive Mouth Rinsescore 9.4 · 1 generation · 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
*	K150074	Elevate Moisturizing Spray Summary page 5 …uct Code: LFD Predicate Device Primary Predicate Device 510(k) Elevate Moisturizing Spray K150074 Reference Device 510(k) Biotene Dry Mouth Rinse K123731…	Elevate Oral Care	2015	—
†	K123731	Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, Biotene Moisturizing Mouth Spray	Glaxosmithkline Consumer Healthcare (Gskch)	2013	1

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 13 years and passes through 2 companies; a new generation was cleared every 10.7 years on median.
1 of the 2 ancestors has a recall of any class.

How does its category compare?

All LFD devices

LFD Saliva, Artificial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?

Allday Moisturizing Rinse is indicated to provide relief from dry mouth, clean, refresh, and soothe oral tissues. It is recommended to be used by people who may experience difficulties in eating, speaking or are suffering from discomfort due to dry mouth.

Allday Moisturizing Rinse is indicated for rapid relief of dry mouth symptoms, to provide a protective coating inside the mouth and to help control bad breath.

A mouth rinse that quickly reduces mouth discomfort, oral malodor and other symptoms of dry mouth.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K253778 · printed Nov 5, 2026

Cite this page

510(k) Report. “K253778: Allday Moisturizing Rinse.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253778

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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