510(k) · Cleared

Cleared

CloSYS® Dry Mouth Sensitive Mouth Rinse

K250390510(k) TraditionalCleared May 19, 202597-day reviewClass U

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

Rowpar Pharmaceuticals, Inc. · LFD Saliva, Artificial

Cleared on May 19, 2025 as substantially equivalent to K123731 (Glaxosmithkline Consumer Healthcare (Gskch), 2013) after a 97-day review. Its family tree reaches back 1 generation to 2013.

Decided: May 19, 2025
Review: 97 days
Class: Class U
Product code: LFD
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K123731 (2013). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK123731 Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, Biotene…Glaxosmithkline Consumer Healthcare (Gskch) · 2013 · Recalled
This deviceK250390 CloSYS® Dry Mouth Sensitive Mouth RinseRowpar Pharmaceuticals, Inc. · 2025

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)	K250390	CloSYS® Dry Mouth Sensitive Mouth Rinse	Rowpar Pharmaceuticals, Inc.	2025	—

FIG. 1 — Lineage of K250390, 2013–2025Source: 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 5 …own): Saliva, Artificial 4. IDENTIFICATION OF EQUIVALENCE GlaxoSmithKline Consumer Healthcare: Bioténe Dry Mouth Mouthwash & Biotene PBF Dry Mouth Mouthwash cleared in K123731 — Predicate Device. Biopharm Consults LLC: Hydris™ Oral Rinse cleared in K163029 — Reference Device S. DEVICE DESCRIPTION CI6S…	Glaxosmithkline Consumer Healthcare (Gskch)	2013	1
†	K163029	Hydris™ Oral Rinse	Biopharm Consult, LLC	2017	—

Also cleared against K123731: 8 other devices →

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?

Its one ancestor has a recall.
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. 2025, 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?

Relieves the symptom and discomfort of dry mouth, refreshes, moisturizes/hydrates, and lubricates oral dryness.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K250390 · printed Nov 5, 2026

Cite this page

510(k) Report. “K250390: CloSYS® Dry Mouth Sensitive Mouth Rinse.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K250390

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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