510(k) · Cleared

Cleared

MedActive Oral Gel and Spray

K152201510(k) TraditionalCleared Dec 30, 2015146-day reviewClass U

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

Medactive Oral Pharmaceuticals, LLC · LFD Saliva, Artificial

Cleared on Dec 30, 2015 as substantially equivalent to K123731 (Glaxosmithkline Consumer Healthcare (Gskch), 2013) after a 146-day review. Its family tree reaches back 1 generation to 2013. 1 later device descends from it.

Decided: Dec 30, 2015
Review: 146 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 deviceK152201 MedActive Oral Gel and SprayMedactive Oral Pharmaceuticals, LLC · 2015
Descendant · cites it directly · 0 of its ownK171542 TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth LozengesDr. Harold Katz, LLC (Dba Therabreath · 2018

Most influential descendants

Showing 1 of 1 · See all

K171542TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth LozengesDr. Harold Katz, LLC (Dba Therabreath · 2018 · 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)	K152201	MedActive Oral Gel and Spray	Medactive Oral Pharmaceuticals, LLC	2015	—
+1	K171542	TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges	Dr. Harold Katz, LLC (Dba Therabreath	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	1	0

FIG. 1 — Lineage of K152201, 2013–2018Source: 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 …LFD Predicate Devices Primary Device 510(k) Biotene Moisturizing Mouth Spray K123731 Reference Devices 510(k) GC Moisturizing Gel…	Glaxosmithkline Consumer Healthcare (Gskch)	2013	1
†	K101346	GC Oral Moisturizing Gel	GC America, Inc.	2011	—
†	K061331	Oral Balance Liquid/ Gel	Laclede, Inc.	2006	—

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
K171542	TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges	Dr. Harold Katz, LLC (Dba Therabreath	2018	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, K171542 (Dr. Harold Katz, LLC (Dba Therabreath, 2018) 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?

1. Provides symptom relief from Dry Mouth and low saliva including:

Oral discomfort

Mucosal soft tissue dryness

Oral side effects of illness, therapies, and medications

2. Soothes moistens and lubricates

3. Hydrates soft tissue

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K152201 · printed Nov 3, 2026

Cite this page

510(k) Report. “K152201: MedActive Oral Gel and Spray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K152201

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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