510(k) · Cleared
ClearedSalinum, Orclair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sinclair Pharmaceuticals, Ltd. · LFD Saliva, Artificial
Cleared on Sep 15, 2003 as substantially equivalent to K981693 (Gebauer Co., 2001) and 1 other predicate after a 273-day review. Its family tree reaches back 2 generations to 1988. 19 later devices descend from it.
- Decided
- Sep 15, 2003
- Review
- 273 days
- Class
- Class U
- Product code
- LFD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K874106 (1988). 3 ancestors in all. 19 later devices descend from it, 7 citing it directly.
- Root · 2 generations backK874106 Glandosane (Salivart) Synthetic SalivaFresenius USA, Inc. · 1988
- 1 generation backK991938 Caphosol Artificial SalivaInpharma A.S. · 1999
- This deviceK024148 Salinum, OrclairSinclair Pharmaceuticals, Ltd. · 2003
- Descendant · cites it directly · 16 of its ownK051812 Tgo SprayLaboratoires Carilene S.A.S. · 2005
- Descendant · cites it directly · 13 of its ownK061331 Oral Balance Liquid/ GelLaclede, Inc. · 2006
- Descendant · 2 generations on · 6 of its ownK101477 Biotene Dry Mouth Mouthwash, Biotene PBF Dry Mouth MouthwashGlaxosmithkline Consumer Healthcare (Gskch) · 2010
- Descendant · cites it directly · 3 of its ownK062653 Mouthkote Oral Moisturizer, Model 50930-098Parnell Pharmaceuticals, Inc. · 2006
- Descendant · 3 generations on · 2 of its ownK111250 Dry Mouth MouthwashDr. Fresh, Inc. · 2012
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K051812Tgo SprayLaboratoires Carilene S.A.S. · 2005 · cites it directly16descendants
- K061331Oral Balance Liquid/ GelLaclede, Inc. · 2006 · cites it directly13descendants
- K101477Biotene Dry Mouth Mouthwash, Biotene PBF Dry Mouth MouthwashGlaxosmithkline Consumer Healthcare (Gskch) · 2010 · 2 generations on6descendants
- K062653Mouthkote Oral Moisturizer, Model 50930-098Parnell Pharmaceuticals, Inc. · 2006 · cites it directly3descendants
- K111250Dry Mouth MouthwashDr. Fresh, Inc. · 2012 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K874106 | Glandosane (Salivart) Synthetic Saliva | Fresenius USA, Inc. | 1988 | — |
| −1 | K991938 | Caphosol Artificial Saliva | Inpharma A.S. | 1999 | — |
| 0 (this device) | K024148 | Salinum, Orclair | Sinclair Pharmaceuticals, Ltd. | 2003 | — |
| +1 | K051812 | Tgo Spray | Laboratoires Carilene S.A.S. | 2005 | — |
| +1 | K061331 | Oral Balance Liquid/ Gel | Laclede, Inc. | 2006 | — |
| +2 | K101477 | Biotene Dry Mouth Mouthwash, Biotene PBF Dry Mouth Mouthwash | Glaxosmithkline Consumer Healthcare (Gskch) | 2010 | — |
| +1 | K062653 | Mouthkote Oral Moisturizer, Model 50930-098 | Parnell Pharmaceuticals, Inc. | 2006 | — |
| +3 | K111250 | Dry Mouth Mouthwash | Dr. Fresh, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
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
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | K981693 | Salivart Oral Moisturizer Model Number 03866-009-75 Salivart Oral Moisturizer Model…Summary page 1…assification Name,s: Dental: Saliva, artificial 3. Devices to Which New Device is Substantially Equivalent: Gebauer Company: Salivart cleared in 5 1O(k) K98 1693 and Inpharma AB: Caphosol cleared in 510(k) K991938 cx 4. Device Description: SALINUMO / ORACLAIR is an oral saliva subs… | 2001 |
| * | K991938 | Caphosol Artificial SalivaSummary page 1…tificial 3. Devices to Which New Device is Substantially Equivalent: Gebauer Company: Salivart cleared in 5 1O(k) K98 1693 and Inpharma AB: Caphosol cleared in 510(k) K991938 cx 4. Device Description: SALINUMO / ORACLAIR is an oral saliva substitute which contains gel-forming substances (polysa… | 1999 |
What descends from it? (19)
See all 197 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051812 | Tgo Spray | 2005 | 16 |
| K061331 | Oral Balance Liquid/ Gel | 2006 | 13 |
| K062653 | Mouthkote Oral Moisturizer, Model 50930-098 | 2006 | 3 |
| K072306 | Bioxtra Moisturizing Gel | 2007 | 2 |
| K163476 | Lubricity | 2017 | 0 |
| K071617 | Oral Neutralizer | 2007 | 0 |
| K041563 | Oasis Dry Mouth Relief Discs or Oasis Mouth Moisturizing Discs | 2004 | 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?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 11.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K051812 (Laboratoires Carilene S.A.S., 2005) has gone furthest, with 16 descendants of its own.
- 7 other devices also cite its predicate K981693.
How does its category compare?
All LFD devicesLFD Saliva, Artificial: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LFD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LFD
287in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LFD
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFD
11in 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?
Under the supervision of a healthcare professional,
SALINUM® has been formulated for the relief of chronic and
temporary xerostomia (dry mouth), which may be a result of
disease, medication, oncology therapy, stress or aging.
ORACLAIR has been formulated for the relief of dry mouth
symptoms such as difficulties 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.
https://510kreport.com/device/K024148 · printed Nov 3, 2026
Cite this page
510(k) Report. “K024148: Salinum, Orclair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024148
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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