510(k) · Cleared
ClearedVicks Powershot Dry Throat & Mouth Relief
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Procter & Gamble Co. · LFD Saliva, Artificial
Cleared on Aug 28, 2009 as substantially equivalent to K810157 (Kingswood Laboratories, Inc., 1981) and 2 other predicates after a 107-day review. Its family tree reaches back 1 generation to 1981. 2 later devices descend from it.
- Decided
- Aug 28, 2009
- Review
- 107 days
- Class
- Class U
- Product code
- LFD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K810157 (1981). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK810157 Moi-StirKingswood Laboratories, Inc. · 1981
- This deviceK091419 Vicks Powershot Dry Throat & Mouth ReliefThe Procter & Gamble Co. · 2009
- Descendant · cites it directly · 1 of its ownK110116 Xeros Dry Mouth PumpLorin Technologies Corporation · 2011
- Descendant · 2 generations on · 0 of its ownK173808 Voutia™Jeffrey Ward Cash, Dds · 2018
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 |
|---|---|---|---|---|---|
| −1 | K810157 | Moi-Stir | Kingswood Laboratories, Inc. | 1981 | — |
| 0 (this device) | K091419 | Vicks Powershot Dry Throat & Mouth Relief | The Procter & Gamble Co. | 2009 | — |
| +1 | K110116 | Xeros Dry Mouth Pump | Lorin Technologies Corporation | 2011 | — |
| +2 | K173808 | Voutia™ | Jeffrey Ward Cash, Dds | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K810157 | Moi-StirSummary page 2…the cited predicate devices. Product Name Company Class Intended use Moi-Stir, K810157 Kingswood Unclassified For the relief of dry Laboratories, Inc.… | 1981 |
| * | K840807 | Throat Moi-StirSummary page 2…Laboratories, Inc. mouth and dry throat Throat Moi-Stir, Kingswood Unclassified For the relief of dry K840807 Laboratories, Inc. throat Saliva Substitute, Roxane Laboratories,… | 1984 |
| * | K822971 | Saliva SubstituteSummary page 2…Laboratories, Inc. throat Saliva Substitute, Roxane Laboratories, Unclassified For immediate and K822971 Inc. effective relief of dry… | 1982 |
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 |
|---|---|---|---|
| K110116 | Xeros Dry Mouth Pump | 2011 | 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?
- None of the 3 ancestors has a recall.
- Of its descendants, K110116 (Lorin Technologies Corporation, 2011) has gone furthest, with 1 descendant of its own.
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?
Vicks Powershot Dry Throat and Mouth Relief Spray - For immediate and effective relief of dry throat and dry mouth by coating, moistening and lubricating.
Vicks Powershot Dry Throat and Mouth Relief Liquid - For immediate and effective relief of dry throat and dry mouth by coating, moistening and lubricating.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091419 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091419: Vicks Powershot Dry Throat & Mouth Relief.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091419
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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