510(k) Report

510(k) · Cleared

Cleared

Invent Snoring Device

K120665510(k) TraditionalCleared Jun 12, 201299-day reviewClass I21 CFR 874.3900

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

Ventus Medical, Inc. · LWF Dilator, Nasal

Cleared on Jun 12, 2012 after a 99-day review. The FDA summary names its predicate without a number. 1 later device descends from it.

Decided
Jun 12, 2012
Review
99 days
Class
Class I
Product code
LWF
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2018: 1 descendant cleared2010201520202025
  1. This deviceK120665 Invent Snoring DeviceVentus Medical, Inc. · 2012
  2. Descendant · cites it directly · 0 of its ownK181219 OptiPillows EPAP MaskCpapnea Medical Supply · 2018

Most influential descendants

Showing 1 of 1 · See all
  • K181219OptiPillows EPAP MaskCpapnea Medical Supply · 2018 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K120665Invent Snoring DeviceVentus Medical, Inc.2012—
+1K181219OptiPillows EPAP MaskCpapnea Medical Supply2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
FIG. 1 — Lineage of K120665, 2012–2018Source: 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), 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 LWF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*—BR2 Nasal Dilator
Named without a submission number
—

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K181219OptiPillows EPAP MaskCpapnea Medical Supply20180

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, K181219 (Cpapnea Medical Supply, 2018) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LWF devices

LWF Dilator, Nasal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · LWF

1in 2018

2012: 12018: 1
2007high 1 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LWF

Too few LWF 510(k)s in any year since 2007 to give a median.

Recalls per year · LWF

No recall names LWF since 2007.

Adverse event reports per year · LWF

8in 2024

2007: 52008: 42009: 32010: 42011: 92012: 122013: 102014: 122015: 412016: 392017: 132018: 152019: 132020: 62021: 42022: 52023: 22024: 8
2007high 41 (2015) · low 0 (2025)2025

MAUDE reports naming product code LWF, 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
20070—05
20080—04
20090—03
20100—04
20110—09
20121—012
20130—010
20140—012
20150—041
20160—039
20170—013
20181—015
20190—013
20200—06
20210—04
20220—05
20230—02
20240—08
20250—00
20260—0—

What is it indicated for?

The In Vent Snoring Device is intended to reduce or eliminate snoring.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K120665: Invent Snoring Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120665

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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