510(k) · Cleared
ClearedApnearx
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apnea Science Corporation · LRK Device, Anti-Snoring
Cleared on Mar 1, 2012 as substantially equivalent to K112205 (Consumer Health Products, Inc., 2011) and 4 other predicates after a 90-day review. Its family tree reaches back 4 generations to 2007. 4 later devices descend from it.
- Decided
- Mar 1, 2012
- Review
- 90 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K071404 (2007). 12 ancestors in all, the oldest K882303 (1989). 4 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK071404 Sleep Right - Select, Low Profile and AdvancePower Products, Inc.-Splintek · 2007
- 3 generations backK100545 SleeprightPower Products, Inc.-Splintek · 2010
- 2 generations backK103004 Snore GuardRanir, LLC · 2011
- 1 generation backK112205 Snorerx 9.0Consumer Health Products, Inc. · 2011
- This deviceK113569 ApnearxApnea Science Corporation · 2012
- Descendant · cites it directly · 1 of its ownK223901 ApneaRX ProApnea Sciences Coporation · 2023
- Descendant · 2 generations on · 0 of its ownK250122 SleepRight Snore AidSplintek, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK181396 Oral Device OA, Oral Device SPassion For Life Healthcare (Uk) Limited · 2018
- Descendant · cites it directly · 0 of its ownK162192 BlueProBluesom · 2016
Most influential descendants
Showing 4 of 4 · See all- K223901ApneaRX ProApnea Sciences Coporation · 2023 · cites it directly1descendant
- K250122SleepRight Snore AidSplintek, Inc. · 2025 · 2 generations on0descendants
- K181396Oral Device OA, Oral Device SPassion For Life Healthcare (Uk) Limited · 2018 · cites it directly0descendants
- K162192BlueProBluesom · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K071404 | Sleep Right - Select, Low Profile and Advance | Power Products, Inc.-Splintek | 2007 | — |
| −3 | K100545 | Sleepright | Power Products, Inc.-Splintek | 2010 | — |
| −2 | K103004 | Snore Guard | Ranir, LLC | 2011 | — |
| −1 | K112205 | Snorerx 9.0 | Consumer Health Products, Inc. | 2011 | — |
| 0 (this device) | K113569 | Apnearx | Apnea Science Corporation | 2012 | — |
| +1 | K223901 | ApneaRX Pro | Apnea Sciences Coporation | 2023 | — |
| +2 | K250122 | SleepRight Snore Aid | Splintek, Inc. | 2025 | — |
| +1 | K181396 | Oral Device OA, Oral Device S | Passion For Life Healthcare (Uk) Limited | 2018 | — |
| +1 | K162192 | BluePro | Bluesom | 2016 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (5)
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 |
|---|---|---|---|
| * | K112205 | Snorerx 9.0Summary page 1…ces Corporation ApneaRx is substantially equivalent in intended use, principal of operation and technological characteristics to the Consumer Health Products "SnoreRx (1(112205), Respironics "Custom 1"(K(033822), SnoreFree (K955336), OSAP, (K(960673), SnoreMaster (PureSleep) (K(954128), as well as other p… | 2011 |
| * | K033822 | Respironics Custom I Oral ApplianceSummary page 1…lass H PRODUOF CODE LRK PREDICATE DEVICES: Consumer Health Products "SnoreRx" (KI 12205), Respironics Custom 1, (K033822) SnoreFree (K(955336), OSAP, (K960673), SnoreMaster (PureSleep) (K(954128). Substantially Equivalen… | 2004 |
| * | K955336 | SnorefreeSummary page 1…intended use, principal of operation and technological characteristics to the Consumer Health Products "SnoreRx (1(112205), Respironics "Custom 1"(K(033822), SnoreFree (K955336), OSAP, (K(960673), SnoreMaster (PureSleep) (K(954128), as well as other predicate devices cleared with an LRK Product Code. De… | 1996 |
| * | K960673 | OSAPSummary page 1…RK PREDICATE DEVICES: Consumer Health Products "SnoreRx" (KI 12205), Respironics Custom 1, (K033822) SnoreFree (K(955336), OSAP, (K960673), SnoreMaster (PureSleep) (K(954128). Substantially Equivalent To: The Apnea Sciences Corporation A… | 1996 |
| * | K954128 | SnoremasterSummary page 1…" (KI 12205), Respironics Custom 1, (K033822) SnoreFree (K(955336), OSAP, (K960673), SnoreMaster (PureSleep) (K(954128). Substantially Equivalent To: The Apnea Sciences Corporation ApneaRx is substantially equivalent in intended use, principal of… | 1995 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 5 years and passes through 4 companies; a new generation was cleared every 9 months on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K223901 (Apnea Sciences Coporation, 2023) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K112205.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Apnea Sciences Corporation "Apnealtx" is intended for use on adult patients 18 years of age or older as an aid for the reduction of mild to moderate obstructive sleep apnea (OSA), and/or snoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113569 · printed Nov 5, 2026
Cite this page
510(k) Report. “K113569: Apnearx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K113569
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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