510(k) · Cleared

Recalled · Class II · 2021

G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray

K181134510(k) TraditionalCleared Jul 13, 201874-day reviewClass URecalls 1

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

Sunstar Americas, Inc. · LFD Saliva, Artificial

Cleared on Jul 13, 2018 as substantially equivalent to K123731 (Glaxosmithkline Consumer Healthcare (Gskch), 2013) after a 74-day review. Its family tree reaches back 1 generation to 2013. 2 later devices descend from it. It has been recalled once.

Decided: Jul 13, 2018
Review: 74 days
Class: Class U
Product code: LFD
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K123731 (2013). 2 later devices descend 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 deviceK181134 G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse…Sunstar Americas, Inc. · 2018
Descendant · cites it directly · 1 of its ownK201277 Oral-B Dry Mouth Oral RinseThe Procter & Gamble Company · 2020
Descendant · 2 generations on · 0 of its ownK203567 Oral-B Dry Mouth Oral RinseThe Procter & Gamble Company · 2021

Most influential descendants

Showing 2 of 2 · See all

K201277Oral-B Dry Mouth Oral RinseThe Procter & Gamble Company · 2020 · cites it directly1descendant
K203567Oral-B Dry Mouth Oral RinseThe Procter & Gamble Company · 2021 · 2 generations on0descendants

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)	K181134	G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M…	Sunstar Americas, Inc.	2018	—
+1	K201277	Oral-B Dry Mouth Oral Rinse	The Procter & Gamble Company	2020	—
+2	K203567	Oral-B Dry Mouth Oral Rinse	The Procter & Gamble Company	2021	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2020	1	0
2021	1	0

FIG. 1 — Lineage of K181134, 2013–2021Source: 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? (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 …Dental Devices Panel Predicate Device: Biotene® Oral Balance® Dry Mouth Moisturizing Gel and Biotene Dry Mouth Oral Rinse and Biotene Dry Mouth Spray, K123731. Description of the Device G•U•M® HYDRAL™ Dry Mouth Oral Gel, G•U•M® HYDRAL™ Dry Mouth Oral Rinse and G•U•M® HYDRAL™ Dry Mouth…	Glaxosmithkline Consumer Healthcare (Gskch)	2013	1

Also cleared against K123731: 8 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K201277	Oral-B Dry Mouth Oral Rinse	The Procter & Gamble Company	2020	1

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 18, 2021	Class II	Z-1182-2021	Process control	The product may be contaminated with Burkholderia cepacia

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K201277 (The Procter & Gamble Company, 2020) has gone furthest, with 1 descendant 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. 2018, 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?

G•U•M® HYDRAL™ Dry Mouth Oral Gel helps soothe oral tissue and relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation and lubricate oral dryness.

G•U•M® HYDRAL™ Dry Mouth Oral Rinse helps soothe oral tissue and relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation and lubricate oral dryness.

G•U•M® HYDRAL™ Dry Mouth Oral Spray helps soothe oral tissue and relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation and lubricate oral dryness.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K181134 · printed Nov 6, 2026

Cite this page

510(k) Report. “K181134: G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181134

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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