510(k) · Cleared
ClearedOniris; Oniris Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oniris · LRK Device, Anti-Snoring
Cleared on Sep 4, 2025 as substantially equivalent to K200657 (Smartguard Rx, Inc., 2021) after a 209-day review. Its family tree reaches back 7 generations to 2007.
- Decided
- Sep 4, 2025
- Review
- 209 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K071404 (2007). 12 ancestors in all, the oldest K882303 (1989). No later device cites it as a predicate yet.
- Root · 7 generations backK071404 Sleep Right - Select, Low Profile and AdvancePower Products, Inc.-Splintek · 2007
- 6 generations backK100545 SleeprightPower Products, Inc.-Splintek · 2010
- 5 generations backK103004 Snore GuardRanir, LLC · 2011
- 4 generations backK112205 Snorerx 9.0Consumer Health Products, Inc. · 2011
- 3 generations backK153200 SnoreRxApnea Sciences Corporation · 2016
- 2 generations backK170825 SnoreRxApnea Sciences Corporation · 2017
- 1 generation backK200657 SmartGuard Anti-Snoring DeviceSmartguard Rx, Inc. · 2021
- This deviceK250353 Oniris; Oniris PlusOniris · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K071404 | Sleep Right - Select, Low Profile and Advance | Power Products, Inc.-Splintek | 2007 | — |
| −6 | K100545 | Sleepright | Power Products, Inc.-Splintek | 2010 | — |
| −5 | K103004 | Snore Guard | Ranir, LLC | 2011 | — |
| −4 | K112205 | Snorerx 9.0 | Consumer Health Products, Inc. | 2011 | — |
| −3 | K153200 | SnoreRx | Apnea Sciences Corporation | 2016 | — |
| −2 | K170825 | SnoreRx | Apnea Sciences Corporation | 2017 | — |
| −1 | K200657 | SmartGuard Anti-Snoring Device | Smartguard Rx, Inc. | 2021 | — |
| 0 (this device) | K250353 | Oniris; Oniris Plus | Oniris | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1995 | 2 | 0 |
| 1998 | 1 | 0 |
| 2010 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K200657 | SmartGuard Anti-Snoring DeviceSummary page 5…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K200657 SmartGuard LRK Ki066… | 2021 |
| Kept off the family tree | K1066 | Oniris Number could not be read |
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 18 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- None of the 12 ancestors has a recall.
- 1 other device also cites its predicate K200657.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
Oniris and Oniris Plus devices are indicated for use on adult patients 18 years of age or older as an aid for the reduction of snoring (OTC).
Oniris Plus device is indicated in the treatment of snoring and/or mild to moderate obstructive sleep apnea in adults. (Rx)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250353 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250353: Oniris; Oniris Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250353
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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