510(k) · Cleared
ClearedNeutrasal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bartor Pharmacal Co., Inc. · LFD Saliva, Artificial
Cleared on Sep 2, 2009 as substantially equivalent to K030802 (Inpharma A.S., 2003) and 1 other predicate after an 83-day review. Its family tree reaches back 3 generations to 1988. 2 later devices descend from it.
- Decided
- Sep 2, 2009
- Review
- 83 days
- Class
- Class U
- Product code
- LFD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K874106 (1988). 2 later devices descend from it, 1 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 backK030802 CaphosolInpharma A.S. · 2003
- This deviceK091718 NeutrasalBartor Pharmacal Co., Inc. · 2009
- Descendant · cites it directly · 1 of its ownK093642 NeutrasalInvado Pharmaceuticals · 2009
- Descendant · 2 generations on · 0 of its ownK152406 SalivaMAXForward Science, LLC · 2015
Most influential descendants
Showing 2 of 2 · See allView 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 | K030802 | Caphosol | Inpharma A.S. | 2003 | — |
| 0 (this device) | K091718 | Neutrasal | Bartor Pharmacal Co., Inc. | 2009 | — |
| +1 | K093642 | Neutrasal | Invado Pharmaceuticals | 2009 | — |
| +2 | K152406 | SalivaMAX | Forward Science, LLC | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K030802 | CaphosolSummary page 1…ames: Saliva, Artificial C. Regulatory Information: Device Class: Unclassified Product Code: LFD D. Predicates: K030802, K991938 Caphosol ®,Artificial Saliva Product Code: LFD E. Devi… | 2003 |
| * | K991938 | Caphosol Artificial SalivaSummary page 1…Saliva, Artificial C. Regulatory Information: Device Class: Unclassified Product Code: LFD D. Predicates: K030802, K991938 Caphosol ®,Artificial Saliva Product Code: LFD E. Device Descri… | 1999 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093642 | Neutrasal | 2009 | 1 |
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 21 years and passes through 3 companies; a new generation was cleared every 5.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K093642 (Invado Pharmaceuticals, 2009) has gone furthest, with 1 descendant 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. 2009, this device’s year, is highlighted.
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?
(OTC): Neutrasai® is indicated for the dryness of the mouth (hyposalivation, xerostomia) (OTC): Neutrasal® is also indicated for dryness of the oral mucosa due to drugs such as antihistamines or atropine or other anticholinergic agents that suppress salivary secretion. (OTC): Neutrasal® may be used as part of an oral hygiene program for patients with dry mouth. Neutrasal® also provides intensive hygiene of the oral cavity. (Rx): Neutrasal® is also…
Read the full statement (158 words)
(OTC): Neutrasai® is indicated for the dryness of the mouth (hyposalivation, xerostomia)
(OTC): Neutrasal® is also indicated for dryness of the oral mucosa due to drugs such as antihistamines or atropine or other anticholinergic agents that suppress salivary secretion.
(OTC): Neutrasal® may be used as part of an oral hygiene program for patients with dry mouth. Neutrasal® also provides intensive hygiene of the oral cavity.
(Rx): Neutrasal® is also indicated as an adjunct to standard oral care in relieving the discomfort associated with oral mucositis that may be caused by radiation or high dose chemotherapy. Relief of dryness of the oral mucosa in these conditions is associated with amelioration of pain.
(Rx): Neutrasal® may be used for relief of dryness of the oral mucosa when hyposalivation results from the following: surgery, radiotherapy near the salivary glands, chemotherapy, infection or dysfunction ofthe salivary glands; fever; emotional factors such as fear or anxiety; obstruction of the salivary ducts; Sjbgren's syndrome
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091718 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091718: Neutrasal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091718
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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