510(k) Report

510(k) · Cleared

Cleared

Throat Moi-Stir

K840807510(k) TraditionalCleared May 25, 198491-day reviewClass U

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

Kingswood Laboratories, Inc. · LFD Saliva, Artificial

Cleared on May 25, 1984 after a 91-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
May 25, 1984
Review
91 days
Class
Class U
Product code
LFD
Recalls
None
Predicates
0

3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2011: 1 descendant cleared2018: 1 descendant cleared19801990200020102020
  1. This deviceK840807 Throat Moi-StirKingswood Laboratories, Inc. · 1984
  2. Descendant · cites it directly · 2 of its ownK091419 Vicks Powershot Dry Throat & Mouth ReliefThe Procter & Gamble Co. · 2009
  3. Descendant · 2 generations on · 1 of its ownK110116 Xeros Dry Mouth PumpLorin Technologies Corporation · 2011
  4. Descendant · 3 generations on · 0 of its ownK173808 Voutia™Jeffrey Ward Cash, Dds · 2018

Most influential descendants

Showing 3 of 3 · See all
  • K091419Vicks Powershot Dry Throat & Mouth ReliefThe Procter & Gamble Co. · 2009 · cites it directly2descendants
  • K110116Xeros Dry Mouth PumpLorin Technologies Corporation · 2011 · 2 generations on1descendant
  • K173808Voutia™Jeffrey Ward Cash, Dds · 2018 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K840807Throat Moi-StirKingswood Laboratories, Inc.1984—
+1K091419Vicks Powershot Dry Throat & Mouth ReliefThe Procter & Gamble Co.2009—
+2K110116Xeros Dry Mouth PumpLorin Technologies Corporation2011—
+3K173808Voutia™Jeffrey Ward Cash, Dds2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201110
201810
FIG. 1 — Lineage of K840807, 1984–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K253778 Allday Moisturizing Rinsescore 11.2 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K091419Vicks Powershot Dry Throat & Mouth ReliefThe Procter & Gamble Co.20092

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?

  • Of its descendants, K091419 (The Procter & Gamble Co., 2009) has gone furthest, with 2 descendants of its own.

How does its category compare?

All LFD devices

LFD Saliva, Artificial: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LFD

1in 2025

2007: 22009: 32010: 12011: 32012: 22013: 22015: 52017: 32018: 52019: 32020: 12021: 22023: 12024: 22025: 12026 (partial year): 1
2007high 5 (2015) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LFD

287in 2019

2009: 83 days median2011: 209 days median2015: 156 days median2017: 231 days median2018: 210 days median2019: 287 days median
2007high 287 (2019) · low 83 (2009)2026

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

Recalls per year · LFD

1in 2013

2007: 12013: 1
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

2007: 22010: 12011: 52012: 72013: 372014: 192015: 282016: 682017: 512018: 372019: 402020: 342021: 302022: 152023: 102024: 142025: 11
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—12
20080—00
200938300
20101—01
2011320905
20122—07
20132—137
20140—019
20155156028
20160—068
20173231051
20185210037
20193287040
20201—034
20212—030
20220—015
20231—010
20242—014
20251—011
20261—0—
Cite this page

510(k) Report. “K840807: Throat Moi-Stir.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K840807

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026