510(k) · Cleared

Cleared

Neutrasal

K093642510(k) SpecialCleared Dec 11, 200917-day reviewClass U

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

Invado Pharmaceuticals · LFD Saliva, Artificial

Cleared on Dec 11, 2009 as substantially equivalent to K030802 (Inpharma A.S., 2003) and 2 other predicates after a 17-day review. Its family tree reaches back 4 generations to 1988. 1 later device descends from it.

Decided: Dec 11, 2009
Review: 17 days
Class: Class U
Product code: LFD
Recalls: None
Predicates: 3

Its longest line of descent runs back 4 generations to K874106 (1988). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 4 generations backK874106 Glandosane (Salivart) Synthetic SalivaFresenius USA, Inc. · 1988
3 generations backK991938 Caphosol Artificial SalivaInpharma A.S. · 1999
2 generations backK030802 CaphosolInpharma A.S. · 2003
1 generation backK091718 NeutrasalBartor Pharmacal Co., Inc. · 2009
This deviceK093642 NeutrasalInvado Pharmaceuticals · 2009
Descendant · cites it directly · 0 of its ownK152406 SalivaMAXForward Science, LLC · 2015

Most influential descendants

Showing 1 of 1 · See all

K152406SalivaMAXForward Science, LLC · 2015 · cites it directly0descendants

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	K030802	Caphosol	Inpharma A.S.	2003	—
−1	K091718	Neutrasal	Bartor Pharmacal Co., Inc.	2009	—
0 (this device)	K093642	Neutrasal	Invado Pharmaceuticals	2009	—
+1	K152406	SalivaMAX	Forward Science, LLC	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0

FIG. 1 — Lineage of K093642, 1988–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K030802	Caphosol Summary page 1 …n Names: Saliva, Artificial B. Regulatory Information: Device Class: Unclassified Product Code: LFD C. Predicates: K030802, K991938 Caphosol ®, Artificial Saliva Product Code: LFD…	Inpharma A.S.	2003	—
*	K991938	Caphosol Artificial Saliva Summary page 1 …Saliva, Artificial B. Regulatory Information: Device Class: Unclassified Product Code: LFD C. Predicates: K030802, K991938 Caphosol ®, Artificial Saliva Product Code: LFD K091…	Inpharma A.S.	1999	—
*	K091718	Neutrasal Summary page 1 …C. Predicates: K030802, K991938 Caphosol ®, Artificial Saliva Product Code: LFD K091718 Neutrasal Product Code" LFD D. Device Description: Neutrasal®…	Bartor Pharmacal Co., Inc.	2009	—

Also cleared against K030802: 6 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K152406	SalivaMAX	Forward Science, LLC	2015	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 21 years and passes through 4 companies; a new generation was cleared every 5.8 years on median.
None of the 4 ancestors has a recall.
Of its descendants, K152406 (Forward Science, LLC, 2015) has gone furthest, with 0 descendants of its own.
6 other devices also cite its predicate K030802.

How does its category compare?

All LFD devices

LFD 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

2007high 5 (2015) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LFD

287in 2019

2007high 287 (2019) · low 83 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LFD

1in 2013

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

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

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): Neutrasal® 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. Neutrasall also provides intensive hygiene of the oral cavity. (Rx): Neutrasal® is also…

Read the full statement (155 words)

(OTC): Neutrasal® 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. Neutrasall also provides intensive hygiene of the oral cavity.

(Rx): Neutrasal® is also indicated as an adjunct to standard oral care in treating the 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 of the 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/K093642 · printed Nov 4, 2026

Cite this page

510(k) Report. “K093642: Neutrasal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093642

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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