510(k) · Cleared
ClearedOral Device OA, Oral Device S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Passion For Life Healthcare (Uk) Limited · LRK Device, Anti-Snoring
Cleared on Nov 16, 2018 as substantially equivalent to K113569 (Apnea Science Corporation, 2012) and 1 other predicate after a 171-day review. Its family tree reaches back 6 generations to 2007.
- Decided
- Nov 16, 2018
- Review
- 171 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K071404 (2007). 15 ancestors in all, the oldest K882303 (1989). No later device cites it as a predicate yet.
- Root · 6 generations backK071404 Sleep Right - Select, Low Profile and AdvancePower Products, Inc.-Splintek · 2007
- 5 generations backK100545 SleeprightPower Products, Inc.-Splintek · 2010
- 4 generations backK103004 Snore GuardRanir, LLC · 2011
- 3 generations backK112205 Snorerx 9.0Consumer Health Products, Inc. · 2011
- 2 generations backK153200 SnoreRxApnea Sciences Corporation · 2016
- 1 generation backK170825 SnoreRxApnea Sciences Corporation · 2017
- This deviceK181396 Oral Device OA, Oral Device SPassion For Life Healthcare (Uk) Limited · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K071404 | Sleep Right - Select, Low Profile and Advance | Power Products, Inc.-Splintek | 2007 | — |
| −5 | K100545 | Sleepright | Power Products, Inc.-Splintek | 2010 | — |
| −4 | K103004 | Snore Guard | Ranir, LLC | 2011 | — |
| −3 | K112205 | Snorerx 9.0 | Consumer Health Products, Inc. | 2011 | — |
| −2 | K153200 | SnoreRx | Apnea Sciences Corporation | 2016 | — |
| −1 | K170825 | SnoreRx | Apnea Sciences Corporation | 2017 | — |
| 0 (this device) | K181396 | Oral Device OA, Oral Device S | Passion For Life Healthcare (Uk) Limited | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 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 LRK? 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 LRK device
- #1 K252531 Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for…score 16.3 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K113569 | ApnearxSummary page 5…d obstructive sleep apnea CFR Number: 21 CFR 872.5570 Class: 2 Predicate Devices: Oral Device-OA - K113569 – ApneaRx Oral Device-S - K170825 – SnoreRx Device Description Passion for Life Healthcare U… | 2012 |
| * | K170825 | SnoreRxSummary page 5…72.5570 Class: 2 Predicate Devices: Oral Device-OA - K113569 – ApneaRx Oral Device-S - K170825 – SnoreRx Device Description Passion for Life Healthcare UK Limited is offering two devices: 1) the Oral Device-S is an OTC devi… | 2017 |
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?
- The line of descent spans 11 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- None of the 15 ancestors has a recall.
- 2 other devices also cite its predicate K113569.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · LRK
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LRK
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LRK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LRK
653in 2025
MAUDE reports naming product code LRK, 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 | 1 | — | 0 | 0 |
| 2008 | 3 | 109 | 0 | 1 |
| 2009 | 3 | 88 | 2 | 11 |
| 2010 | 8 | 195 | 0 | 7 |
| 2011 | 10 | 134 | 0 | 69 |
| 2012 | 10 | 142 | 0 | 445 |
| 2013 | 9 | 233 | 0 | 72 |
| 2014 | 11 | 219 | 0 | 49 |
| 2015 | 6 | 117 | 0 | 28 |
| 2016 | 10 | 157 | 0 | 18 |
| 2017 | 7 | 170 | 0 | 32 |
| 2018 | 10 | 200 | 0 | 61 |
| 2019 | 13 | 150 | 0 | 56 |
| 2020 | 5 | 80 | 0 | 24 |
| 2021 | 10 | 126 | 0 | 49 |
| 2022 | 11 | 154 | 0 | 40 |
| 2023 | 5 | 156 | 0 | 50 |
| 2024 | 6 | 254 | 0 | 185 |
| 2025 | 14 | 107 | 1 | 653 |
| 2026 | 10 | 63 | 1 | — |
What is it indicated for?
The Oral Device-OA is intended to reduce night-time snoring and / or mild to moderate obstructive sleep apnea (OSA) for adults 18 and older.
The Oral Device-S is intended to reduce night time snoring for adults 18 and older.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K181396 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181396: Oral Device OA, Oral Device S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181396
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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