510(k) Report

510(k) · Cleared

Cleared

Oramoist

K122663510(k) TraditionalCleared May 30, 2013272-day reviewClass U

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

Quantum, Inc. · LFD Saliva, Artificial

Cleared on May 30, 2013 as substantially equivalent to K051409 (Scandinavian Formulas, Inc., 2005) after a 272-day review. Its family tree reaches back 1 generation to 2005.

Decided
May 30, 2013
Review
272 days
Class
Class U
Product code
LFD
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K051409 (2005). No later device cites it as a predicate yet.

K051409 · Slivasure · Scandinavian Formulas, Inc. · 200520062008201020122014
K051409 · Slivasure · Scandinavian Formulas, Inc. · 20050
  1. Root · 1 generation backK051409 SlivasureScandinavian Formulas, Inc. · 2005
  2. This deviceK122663 OramoistQuantum, Inc. · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K051409SlivasureScandinavian Formulas, Inc.2005—
0 (this device)K122663OramoistQuantum, Inc.2013—
FIG. 1 — Lineage of K122663, 2005–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K051409Slivasure
Summary page 1
…ent Company IDevice K Number I Scandinavian Formulas SalivaSure Tablets K05 1409 Device Description OraMoistR Patches for Dry Mouth is formulated as an oral tablet that adheres to soft tissues of the mouth and…
Scandinavian Formulas, Inc.2005—

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 no recall.

How does its category compare?

All LFD devices

LFD Saliva, Artificial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

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?

OraMoist" Patches for Dry Mouth promotes lubrication of the oral mucosa that may be dry due to side effects of medication, chemo or radiation therapy, or as a symptom of Sjogren's syndrome, or because of oral inflammation. OraMoist" Patches for Dry Mouth provides temporary relief for dry mouth.

Indications for use as stated in the FDA summary.

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/K122663 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122663: Oramoist.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122663

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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