510(k) · Cleared
ClearedOptiPillows EPAP Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cpapnea Medical Supply · LWF Dilator, Nasal
Cleared on Aug 3, 2018 as substantially equivalent to K120665 (Ventus Medical, Inc., 2012) after an 88-day review. Its family tree reaches back 1 generation to 2012.
- Decided
- Aug 3, 2018
- Review
- 88 days
- Class
- Class I
- Product code
- LWF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K120665 (2012). No later device cites it as a predicate yet.
- Root · 1 generation backK120665 Invent Snoring DeviceVentus Medical, Inc. · 2012
- This deviceK181219 OptiPillows EPAP MaskCpapnea Medical Supply · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K120665 | Invent Snoring Device | Ventus Medical, Inc. | 2012 | — |
| 0 (this device) | K181219 | OptiPillows EPAP Mask | Cpapnea Medical Supply | 2018 | — |
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
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 |
|---|---|---|---|
| * | K120665 | Invent Snoring DeviceSummary page 4…art 10: Tests for Irritation and Skin Sensitization. Predicate Device: 807.92(a) (3) InVent Snoring Device, K120665, 03/05/2012. 1 Device Description:… | 2012 |
| * | — | Theravent Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
How does its category compare?
All LWF devicesLWF Dilator, Nasal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · LWF
1in 2018
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
MAUDE reports naming product code LWF, 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 | 0 | — | 0 | 5 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 9 |
| 2012 | 1 | — | 0 | 12 |
| 2013 | 0 | — | 0 | 10 |
| 2014 | 0 | — | 0 | 12 |
| 2015 | 0 | — | 0 | 41 |
| 2016 | 0 | — | 0 | 39 |
| 2017 | 0 | — | 0 | 13 |
| 2018 | 1 | — | 0 | 15 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
OptiPillows EPAP Mask is intended for use during sleep to alleviate snoring. It is intended for the adult population with
snoring only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181219 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181219: OptiPillows EPAP Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181219
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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