510(k) · Cleared
ClearedAnti-Snoring/Sleep Apnea Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rj & VK Bird Pty, Ltd. · LRK Device, Anti-Snoring
Cleared on Oct 27, 2004 as substantially equivalent to K962516 (Nellcor Puritan Bennett, Inc., 1996) after a 78-day review. Its family tree reaches back 2 generations to 1989. 109 later devices descend from it.
- Decided
- Oct 27, 2004
- Review
- 78 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K882303 (1989). 3 ancestors in all. 109 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 1 generation backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- This deviceK042161 Anti-Snoring/Sleep Apnea DeviceRj & VK Bird Pty, Ltd. · 2004
- Descendant · cites it directly · 86 of its ownK050592 Somnomed Mas RxaSomnomed, Ltd. · 2005
- Descendant · 2 generations on · 32 of its ownK073004 Somnomed BflexSomnomed, Inc. · 2008
- Descendant · 2 generations on · 29 of its ownK103076 DynaflexDyna Flex · 2011
- Descendant · cites it directly · 22 of its ownK061688 Anti-Snoring / Sleep Apnea DeviceTomed Dr. Toussaint GmbH · 2006
- Descendant · 3 generations on · 18 of its ownK121340 Somnodent G2Somnomed, Inc. · 2012
Showing 5 of 109 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 109 · See all- K050592Somnomed Mas RxaSomnomed, Ltd. · 2005 · cites it directly86descendants
- K073004Somnomed BflexSomnomed, Inc. · 2008 · 2 generations on32descendants
- K103076DynaflexDyna Flex · 2011 · 2 generations on29descendants
- K061688Anti-Snoring / Sleep Apnea DeviceTomed Dr. Toussaint GmbH · 2006 · cites it directly22descendants
- K121340Somnodent G2Somnomed, Inc. · 2012 · 3 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −1 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| 0 (this device) | K042161 | Anti-Snoring/Sleep Apnea Device | Rj & VK Bird Pty, Ltd. | 2004 | — |
| +1 | K050592 | Somnomed Mas Rxa | Somnomed, Ltd. | 2005 | — |
| +2 | K073004 | Somnomed Bflex | Somnomed, Inc. | 2008 | — |
| +2 | K103076 | Dynaflex | Dyna Flex | 2011 | — |
| +1 | K061688 | Anti-Snoring / Sleep Apnea Device | Tomed Dr. Toussaint GmbH | 2006 | — |
| +3 | K121340 | Somnodent G2 | Somnomed, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 6 | 0 |
| 2012 | 7 | 0 |
| 2013 | 7 | 0 |
| 2014 | 9 | 0 |
| 2015 | 6 | 0 |
| 2016 | 9 | 0 |
| 2017 | 7 | 0 |
| 2018 | 4 | 0 |
| 2019 | 7 | 0 |
| 2020 | 6 | 0 |
| 2021 | 8 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 6 | 0 |
| 2025 | 6 | 0 |
| 2026 | 6 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K962516 | Tap Anti-Snoring DeviceSummary page 2…872.5570 C. Identification of Legally Marketed Devices 1. AName.: TAP 2. K Number: K962516 3. Date Cleared: September 19, 1996 D. Description of the Device The MDSA is an intraoral dental de… | 1996 |
What descends from it? (109)
See all 1092 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 15 years and passes through 3 companies; a new generation was cleared every 8.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K050592 (Somnomed, Ltd., 2005) has gone furthest, with 86 descendants of its own.
- 12 other devices also cite its predicate K962516.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Prescription Device
Custom-Made
Mandibular Repositioning Device
Reduce Snoring
Treat Mild to Moderate Obstructive Sleep Apnea
Single Patient / Multi-Use
Not for Use in Persons Younger than 18 Years of Age
Home or Sleep Laboratory Environment
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042161 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042161: Anti-Snoring/Sleep Apnea Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042161
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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