510(k) · Cleared

Cleared

Elevate Moisturizing Spray

K150074510(k) TraditionalCleared Jun 19, 2015156-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 Jun 19, 2015 as substantially equivalent to K123731 (Glaxosmithkline Consumer Healthcare (Gskch), 2013) after a 156-day review. Its family tree reaches back 1 generation to 2013. 1 later device descends from it.

Decided: Jun 19, 2015
Review: 156 days
Class: Class U
Product code: LFD
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K123731 (2013). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK123731 Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, Biotene…Glaxosmithkline Consumer Healthcare (Gskch) · 2013 · Recalled
This deviceK150074 Elevate Moisturizing SprayElevate Oral Care · 2015
Descendant · cites it directly · 0 of its ownK253778 Allday Moisturizing RinseElevate Oral Care · 2026

Most influential descendants

Showing 1 of 1 · See all

K253778Allday Moisturizing RinseElevate Oral Care · 2026 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2026	1	0

FIG. 1 — Lineage of K150074, 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 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K123731	Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, Biotene Moisturizing Mouth Spray Summary page 4 …uct Code: LFD Predicate Devices Primary Predicate Device 510(k) Biotene Moisturizing Mouth Spray K123731 Reference Device 510(k) GC Moisturizing Gel K101346…	Glaxosmithkline Consumer Healthcare (Gskch)	2013	1
†	K101346	GC Oral Moisturizing Gel	GC America, Inc.	2011	—

Also cleared against K123731: 8 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K253778	Allday Moisturizing Rinse	Elevate Oral Care	2026	0

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?

Its one ancestor has a recall.
Of its descendants, K253778 (Elevate Oral Care, 2026) has gone furthest, with 0 descendants of its own.
8 other devices also cite its predicate K123731.

How does its category compare?

All LFD devices

LFD Saliva, Artificial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?

Elevate Moisturizing Spray is indicated to provide comfort for individuals suffering from dry mouth. It is recommended to be used by people who may experience difficulties in eating, speaking or are suffering from discomfort due to dry mouth.

Elevate Moisturizing Spray 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 spray 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/K150074 · printed Nov 4, 2026

Cite this page

510(k) Report. “K150074: Elevate Moisturizing Spray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K150074

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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