510(k) · Cleared
ClearedOral Balance Liquid/ Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Laclede, Inc. · LFD Saliva, Artificial
Cleared on Jul 25, 2006 as substantially equivalent to K991938 (Inpharma A.S., 1999) and 3 other predicates after a 74-day review. Its family tree reaches back 4 generations to 1988. 13 later devices descend from it.
- Decided
- Jul 25, 2006
- Review
- 74 days
- Class
- Class U
- Product code
- LFD
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K874106 (1988). 6 ancestors in all. 13 later devices descend from it, 8 citing it directly.
- Root · 4 generations backK874106 Glandosane (Salivart) Synthetic SalivaFresenius USA, Inc. · 1988
- 3 generations backK991938 Caphosol Artificial SalivaInpharma A.S. · 1999
- 2 generations backK024148 Salinum, OrclairSinclair Pharmaceuticals, Ltd. · 2003
- 1 generation backK051812 Tgo SprayLaboratoires Carilene S.A.S. · 2005
- This deviceK061331 Oral Balance Liquid/ GelLaclede, Inc. · 2006
- Descendant · cites it directly · 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 · 2 generations on · 2 of its ownK111250 Dry Mouth MouthwashDr. Fresh, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK103745 Biotene Moisturizing Mouth Spray for Dry Mouth Symptom ReliefGlaxosmithkline Consumer Healthcare (Gskch) · 2011
- Descendant · cites it directly · 2 of its ownK072306 Bioxtra Moisturizing GelBio-X Healthcare S.A. · 2007
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K101477Biotene Dry Mouth Mouthwash, Biotene PBF Dry Mouth MouthwashGlaxosmithkline Consumer Healthcare (Gskch) · 2010 · cites it directly6descendants
- K062653Mouthkote Oral Moisturizer, Model 50930-098Parnell Pharmaceuticals, Inc. · 2006 · cites it directly3descendants
- K111250Dry Mouth MouthwashDr. Fresh, Inc. · 2012 · 2 generations on2descendants
- K103745Biotene Moisturizing Mouth Spray for Dry Mouth Symptom ReliefGlaxosmithkline Consumer Healthcare (Gskch) · 2011 · cites it directly2descendants
- K072306Bioxtra Moisturizing GelBio-X Healthcare S.A. · 2007 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K874106 | Glandosane (Salivart) Synthetic Saliva | Fresenius USA, Inc. | 1988 | — |
| −3 | K991938 | Caphosol Artificial Saliva | Inpharma A.S. | 1999 | — |
| −2 | K024148 | Salinum, Orclair | Sinclair Pharmaceuticals, Ltd. | 2003 | — |
| −1 | K051812 | Tgo Spray | Laboratoires Carilene S.A.S. | 2005 | — |
| 0 (this device) | K061331 | Oral Balance Liquid/ Gel | Laclede, Inc. | 2006 | — |
| +1 | 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 | — |
| +2 | K111250 | Dry Mouth Mouthwash | Dr. Fresh, Inc. | 2012 | — |
| +1 | K103745 | Biotene Moisturizing Mouth Spray for Dry Mouth Symptom Relief | Glaxosmithkline Consumer Healthcare (Gskch) | 2011 | — |
| +1 | K072306 | Bioxtra Moisturizing Gel | Bio-X Healthcare S.A. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 3 | 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? (4)
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 |
|---|---|---|---|
| * | K991938 | Caphosol Artificial SalivaSummary page 1…LED 4. Devices to which new device is substantially eq'.ivalent: Jnpharma AB: Capliasol cleared in K991938 Gebauer Company: Salivart cleared in K98 1693 Sinclair Pharmaceuticals… | 1999 |
| * | K981693 | Salivart Oral Moisturizer Model Number 03866-009-75 Salivart Oral Moisturizer Model…Summary page 1…ly eq'.ivalent: Jnpharma AB: Capliasol cleared in K991938 Gebauer Company: Salivart cleared in K98 1693 Sinclair Pharmaceuticals Saliniim or Oraclair cleared in K024148 Laboratoires Carilene S.AS.… | 2001 |
| * | K024148 | Salinum, OrclairSummary page 1…1938 Gebauer Company: Salivart cleared in K98 1693 Sinclair Pharmaceuticals Saliniim or Oraclair cleared in K024148 Laboratoires Carilene S.AS. TGCO Spray cleared in K051812 5. Device Description: Oral Balance is… | 2003 |
| * | K051812 | Tgo SpraySummary page 1…693 Sinclair Pharmaceuticals Saliniim or Oraclair cleared in K024148 Laboratoires Carilene S.AS. TGCO Spray cleared in K051812 5. Device Description: Oral Balance is an artificial saliva substitute which contains moisturizers, amino acids, milk… | 2005 |
What descends from it? (13)
See all 138 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101477 | Biotene Dry Mouth Mouthwash, Biotene PBF Dry Mouth Mouthwash | 2010 | 6 |
| K062653 | Mouthkote Oral Moisturizer, Model 50930-098 | 2006 | 3 |
| K103745 | Biotene Moisturizing Mouth Spray for Dry Mouth Symptom Relief | 2011 | 2 |
| K072306 | Bioxtra Moisturizing Gel | 2007 | 2 |
| K142549 | Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mouth Spray… | 2015 | 1 |
| K240508 | Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel) | 2024 | 0 |
| K101346 | GC Oral Moisturizing Gel | 2011 | 0 |
| K071617 | Oral Neutralizer | 2007 | 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 18 years and passes through 5 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K101477 (Glaxosmithkline Consumer Healthcare (Gskch), 2010) has gone furthest, with 6 descendants of its own.
- 7 other devices also cite its predicate K991938.
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?
A Refreshing Gel and Liquid that quickly diminishes dry discomfort, mouth odors, and other symptoms of a Dry Mouth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061331 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061331: Oral Balance Liquid/ Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061331
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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