510(k) · Cleared
ClearedSML-OSA2 Appliances
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Selane Products, Inc. · LQZ Device, Jaw Repositioning
Cleared on Jul 27, 2017 as substantially equivalent to K130130 (Selane Products, Inc., 2013) after a 294-day review. Its family tree reaches back 9 generations to 1989.
- Decided
- Jul 27, 2017
- Review
- 294 days
- Class
- Class II
- Product code
- LQZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K882303 (1989). 17 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 deviceK162816 SML-OSA2 AppliancesSelane Products, Inc. · 2017
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 deviceK162816 SML-OSA2 AppliancesSelane Products, Inc. · 2017
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) | K162816 | SML-OSA2 Appliances | Selane Products, Inc. | 2017 | — |
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 |
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 LQZ? 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 LQZ device
- #1 K233754 AIO Breathescore 12.9 · 11 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 |
|---|---|---|---|
| * | K130130 | Atg/SM-Osa AppliancesSummary page 4…ation: 872.5570 Classification Panel: Dental Product Code: LQZ, LRK Predicate Device: ATG/SM-OSA Appliances (K130130). Device Description: The SML-OSA2 APPLIANCES include five device models: Adjustable Sleep Appliance (ASA), Clear Sleep Adjustab… | 2013 |
| † | K935144 | Dentaurum Olympia Latex-Elastics and Dentaurum Latex-Elastics | 1994 |
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 28 years and passes through 8 companies; a new generation was cleared every 2.7 years on median.
- None of the 17 ancestors has a recall.
- 5 other devices also cite its predicate K130130.
How does its category compare?
All LQZ devicesLQZ Device, Jaw Repositioning: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · LQZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LQZ
Too few LQZ 510(k)s in any year since 2007 to give a median.
Recalls per year · LQZ
No recall names LQZ since 2007.
Adverse event reports per year · LQZ
2in 2021
MAUDE reports naming product code LQZ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SML-OSA2 Appliances are intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea in adults. The SML-OSA2 appliances are worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The customized appliance is inserted and removed by the patient and adjusted by the prescribing dentist.
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/K162816 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162816: SML-OSA2 Appliances.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162816
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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