510(k) · Cleared
ClearedTgo Spray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Laboratoires Carilene S.A.S. · LFD Saliva, Artificial
Cleared on Oct 21, 2005 as substantially equivalent to K030802 (Inpharma A.S., 2003) and 2 other predicates after a 108-day review. Its family tree reaches back 3 generations to 1988. 16 later devices descend from it.
- Decided
- Oct 21, 2005
- Review
- 108 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. 16 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK874106 Glandosane (Salivart) Synthetic SalivaFresenius USA, Inc. · 1988
- 2 generations backK991938 Caphosol Artificial SalivaInpharma A.S. · 1999
- 1 generation backK024148 Salinum, OrclairSinclair Pharmaceuticals, Ltd. · 2003
- This deviceK051812 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
- Descendant · 2 generations on · 2 of its ownK103745 Biotene Moisturizing Mouth Spray for Dry Mouth Symptom ReliefGlaxosmithkline Consumer Healthcare (Gskch) · 2011
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- 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
- K103745Biotene Moisturizing Mouth Spray for Dry Mouth Symptom ReliefGlaxosmithkline Consumer Healthcare (Gskch) · 2011 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K874106 | Glandosane (Salivart) Synthetic Saliva | Fresenius USA, Inc. | 1988 | — |
| −2 | K991938 | Caphosol Artificial Saliva | Inpharma A.S. | 1999 | — |
| −1 | K024148 | Salinum, Orclair | Sinclair Pharmaceuticals, Ltd. | 2003 | — |
| 0 (this device) | 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 | — |
| +2 | K103745 | Biotene Moisturizing Mouth Spray for Dry Mouth Symptom Relief | Glaxosmithkline Consumer Healthcare (Gskch) | 2011 | — |
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 | 2 | 0 |
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2015 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K030802 | CaphosolSummary page 1…Class II Panel: Dental D. Devices to Which New Device is Substantially Equivalent: Inpharma AB: Caphasol cleared in K030802 Gebauer Company: Salivart cleared in K981693 Sinclair Pharmaceuticals: Salinum or Oraclair cleared in… | 2003 |
| * | K981693 | Salivart Oral Moisturizer Model Number 03866-009-75 Salivart Oral Moisturizer Model…Summary page 1…s to Which New Device is Substantially Equivalent: Inpharma AB: Caphasol cleared in K030802 Gebauer Company: Salivart cleared in K981693 Sinclair Pharmaceuticals: Salinum or Oraclair cleared in K024148 E. Device Description TGO Spray® is an oral ar… | 2001 |
| * | K024148 | Salinum, OrclairSummary page 1…Caphasol cleared in K030802 Gebauer Company: Salivart cleared in K981693 Sinclair Pharmaceuticals: Salinum or Oraclair cleared in K024148 E. Device Description TGO Spray® is an oral artificial saliva that contains oxygenated triglycerides from corn oil… | 2003 |
What descends from it? (16)
See all 164 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 17 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K061331 (Laclede, Inc., 2006) has gone furthest, with 13 descendants of its own.
- 6 other devices also cite its predicate K030802.
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, TGO Spray® is intended to provide relief from chronic and temporary xerostomia (dry mouth), which may be a result of disease such as Sjdgren's Syndrome, oral inflammation, medication, chemo or radiotherapy, stress or aging. TGO Spray® relieves symptoms of dry mouth such as difficulties in swallowing, speech, and changes in taste.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051812 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051812: Tgo Spray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051812
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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