510(k) · Cleared
ClearedLuco Hybrid Osa Appliance
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Luco Hybrid Osa Appliance, Inc. · LRK Device, Anti-Snoring
Cleared on Dec 18, 2013 as substantially equivalent to K050592 (Somnomed, Ltd., 2005) and 2 other predicates after a 271-day review. Its family tree reaches back 9 generations to 1989.
- Decided
- Dec 18, 2013
- Review
- 271 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K882303 (1989). 19 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 5 generations between
- 3 generations backK061732 TAP-TAirway Management, Inc. · 2006
- 2 generations backK103076 DynaflexDyna Flex · 2011
- 1 generation backK130130 Atg/SM-Osa AppliancesSelane Products, Inc. · 2013
- This deviceK130797 Luco Hybrid Osa ApplianceLuco Hybrid Osa Appliance, Inc. · 2013
Show all 9 generations
- Root · 9 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 8 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 7 generations backK972061 TOAW. Keith Thornton, D.D.S. · 1997
- 6 generations backK022891 The Breathe EZ Anti-Snoring DeviceD&S Redhage · 2003
- 5 generations backK030440 Oasys-Oral Airway SystemMark Abramson, D.D.S., Inc. · 2003
- 4 generations backK060388 Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with…Airway Management, Inc. · 2006
- 3 generations backK061732 TAP-TAirway Management, Inc. · 2006
- 2 generations backK103076 DynaflexDyna Flex · 2011
- 1 generation backK130130 Atg/SM-Osa AppliancesSelane Products, Inc. · 2013
- This deviceK130797 Luco Hybrid Osa ApplianceLuco Hybrid Osa Appliance, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −8 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −7 | K972061 | TOA | W. Keith Thornton, D.D.S. | 1997 | — |
| −6 | K022891 | The Breathe EZ Anti-Snoring Device | D&S Redhage | 2003 | — |
| −5 | K030440 | Oasys-Oral Airway System | Mark Abramson, D.D.S., Inc. | 2003 | — |
| −4 | K060388 | Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with Attachment | Airway Management, Inc. | 2006 | — |
| −3 | K061732 | TAP-T | Airway Management, Inc. | 2006 | — |
| −2 | K103076 | Dynaflex | Dyna Flex | 2011 | — |
| −1 | K130130 | Atg/SM-Osa Appliances | Selane Products, Inc. | 2013 | — |
| 0 (this device) | K130797 | Luco Hybrid Osa Appliance | Luco Hybrid Osa Appliance, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 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? (3)
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 |
|---|---|---|---|
| * | K050592 | Somnomed Mas RxaSummary page 1…and/or Obstructive Sleep Apnea Regulation Number 21 CFR 872.5570 Product Code: LRK Predicate Appliances: SomnoMed MAS K050592 Oravan OSA K121285 ATG/SM-OSA Appliance… | 2005 |
| * | K121285 | Oravan OsaSummary page 1…CFR 872.5570 Product Code: LRK Predicate Appliances: SomnoMed MAS K050592 Oravan OSA K121285 ATG/SM-OSA Appliance K130130 Description of Appliance: The Luco Hybrid OSA Appliance is… | 2013 |
| * | K130130 | Atg/SM-Osa Appliances Cleared while this submission was under review Summary page 1…SomnoMed MAS K050592 Oravan OSA K121285 ATG/SM-OSA Appliance K130130 Description of Appliance: The Luco Hybrid OSA Appliance is a two part (upper and lower) mandibular advancement appliance that ad… | 2013 |
| † | K970205 | Vitallium 2000 Alloy; Vitallium 2000 Plus Alloy; Cobalt Chrome Casting Alloy | 1997 |
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 24 years and passes through 9 companies; a new generation was cleared every 2.5 years on median.
- None of the 19 ancestors has a recall.
- 16 other devices also cite its predicate K050592.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
This appliance is designed to treat primary snoring and mild to moderate obstructive sleep apnea in adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130797 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130797: Luco Hybrid Osa Appliance.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130797
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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