510(k) Report

510(k) · Cleared

Cleared

Oasis Dry Mouth Relief Discs or Oasis Mouth Moisturizing Discs

K041563510(k) TraditionalCleared Aug 27, 200478-day reviewClass U

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

Glaxosmithkline Consumer Healthcare, L.P. · LFD Saliva, Artificial

Cleared on Aug 27, 2004 as substantially equivalent to K981693 (Gebauer Co., 2001) and 2 other predicates after a 78-day review. Its family tree reaches back 3 generations to 1988.

Decided
Aug 27, 2004
Review
78 days
Class
Class U
Product code
LFD
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K874106 (1988). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2003: 1 other ancestor2001: 1 other ancestorK874106 · Glandosane (Salivart) Synthetic Saliva · Fresenius USA, Inc. · 1988K991938 · Caphosol Artificial Saliva · Inpharma A.S. · 1999K023046 · SST Saliva Supporting Tablets · Sinclair Pharmaceuticals, Ltd. · 200219851990199520002005
Other ancestors, by generation 1 generation back: 2 other ancestors K023046 · SST Saliva Supporting Tablets · Sinclair Pharmaceuticals, Ltd. · 2002K991938 · Caphosol Artificial Saliva · Inpharma A.S. · 1999K874106 · Glandosane (Salivart) Synthetic Saliva · Fresenius USA, Inc. · 19880
  1. Root · 3 generations backK874106 Glandosane (Salivart) Synthetic SalivaFresenius USA, Inc. · 1988
  2. 2 generations backK991938 Caphosol Artificial SalivaInpharma A.S. · 1999
  3. 1 generation backK023046 SST Saliva Supporting TabletsSinclair Pharmaceuticals, Ltd. · 2002
  4. This deviceK041563 Oasis Dry Mouth Relief Discs or Oasis Mouth Moisturizing DiscsGlaxosmithkline Consumer Healthcare, L.P. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K874106Glandosane (Salivart) Synthetic SalivaFresenius USA, Inc.1988—
−2K991938Caphosol Artificial SalivaInpharma A.S.1999—
−1K023046SST Saliva Supporting TabletsSinclair Pharmaceuticals, Ltd.2002—
0 (this device)K041563Oasis Dry Mouth Relief Discs or Oasis Mouth Moisturizing DiscsGlaxosmithkline Consumer Healthcare, L.P.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
200310
FIG. 1 — Lineage of K041563, 1988–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K253778 Allday Moisturizing Rinsescore 11.2 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K981693Salivart Oral Moisturizer Model Number 03866-009-75 Salivart Oral Moisturizer Model…
Summary page 1
…urizing Discs 3. Devices to Which New Device is Substanitially Equivalenit: Gebauer Company: Salivart cleared in 5 10(k) K98 1693 Sinclair Phalmaceuticals: SST cleared in 5 10(k) K023046 Sinclair Pharmaceuticals: Sali…
Gebauer Co.20012
*K023046SST Saliva Supporting Tablets
Summary page 1
…ly Equivalenit: Gebauer Company: Salivart cleared in 5 10(k) K98 1693 Sinclair Phalmaceuticals: SST cleared in 5 10(k) K023046 Sinclair Pharmaceuticals: Salinum or Oraclair cleared in 5 10(k) K(024148 4. Device Descri…
Sinclair Pharmaceuticals, Ltd.2002—
*K024148Salinum, Orclair
Summary page 1
…693 Sinclair Phalmaceuticals: SST cleared in 5 10(k) K023046 Sinclair Pharmaceuticals: Salinum or Oraclair cleared in 5 10(k) K(024148 4. Device Description: OASISO is a disc that is allowed to dissolve slowly in the mouth. The pr…
Sinclair Pharmaceuticals, Ltd.2003—

Also cleared against K981693: 7 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?

  • The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
  • 1 of the 5 ancestors has a recall of any class.
  • 7 other devices also cite its predicate K981693.

How does its category compare?

All LFD devices

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

FDA decisions per year · LFD

1in 2025

2007: 22009: 32010: 12011: 32012: 22013: 22015: 52017: 32018: 52019: 32020: 12021: 22023: 12024: 22025: 12026 (partial year): 1
2007high 5 (2015) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LFD

287in 2019

2009: 83 days median2011: 209 days median2015: 156 days median2017: 231 days median2018: 210 days median2019: 287 days median
2007high 287 (2019) · low 83 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LFD

1in 2013

2007: 12013: 1
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

2007: 22010: 12011: 52012: 72013: 372014: 192015: 282016: 682017: 512018: 372019: 402020: 342021: 302022: 152023: 102024: 142025: 11
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—12
20080—00
200938300
20101—01
2011320905
20122—07
20132—137
20140—019
20155156028
20160—068
20173231051
20185210037
20193287040
20201—034
20212—030
20220—015
20231—010
20242—014
20251—011
20261—0—

What is it indicated for?

Under the supervision of a healthcare professional, OASIS® dry mouth relief discs have been formulated for the relief of chronic and temporary xerostomia (dry mouth), which may be a result of diseases such as Sjogren's Syndrome, oral inflammation, medication, chemo or radiotherapy, stress or aging.

OASIS® mouth moisturizing discs have been formulated for relief of dry mouth symptoms such as'difficutties in swallowing, speech and changes in taste. These symptoms may be brought on by disease, stress, aging or medication.

Indications for use as stated in the FDA summary.

Also cleared against K981693

7 other devices cite the same predicate.

  • K072306Bioxtra Moisturizing GelBio-X Healthcare S.A. · 2007
  • K071617Oral NeutralizerOral Biotech · 2007
  • K062653Mouthkote Oral Moisturizer, Model 50930-098Parnell Pharmaceuticals, Inc. · 2006
  • K061331Oral Balance Liquid/ GelLaclede, Inc. · 2006
  • K051812Tgo SprayLaboratoires Carilene S.A.S. · 2005
  • K024148Salinum, OrclairSinclair Pharmaceuticals, Ltd. · 2003

Recent decisions in LFD

The LFD category page

  • K253778Allday Moisturizing RinseElevate Oral Care · 2026
  • K250390CloSYS® Dry Mouth Sensitive Mouth RinseRowpar Pharmaceuticals, Inc. · 2025
  • K240508Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)Laclede, Inc. · 2024
  • K234015Caphosol® Artifical Saliva (32 doses sachet box)Eusa Pharma (Uk) Limited · 20241 recall
  • K231205GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral SprayGurunanda, LLC · 2023

https://510kreport.com/device/K041563 · printed Nov 5, 2026

Cite this page

510(k) Report. “K041563: Oasis Dry Mouth Relief Discs or Oasis Mouth Moisturizing Discs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041563

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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