510(k) · Cleared
ClearedPantino Pro Positiner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Somnomed, Inc. · LRK Device, Anti-Snoring
Cleared on Mar 28, 2011 as substantially equivalent to K050592 (Somnomed, Ltd., 2005) and 2 other predicates after a 207-day review. Its family tree reaches back 7 generations to 1989.
- Decided
- Mar 28, 2011
- Review
- 207 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K882303 (1989). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 6 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 5 generations backK972061 TOAW. Keith Thornton, D.D.S. · 1997
- 4 generations backK022891 The Breathe EZ Anti-Snoring DeviceD&S Redhage · 2003
- 3 generations backK030440 Oasys-Oral Airway SystemMark Abramson, D.D.S., Inc. · 2003
- 2 generations backK060388 Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with…Airway Management, Inc. · 2006
- 1 generation backK061732 TAP-TAirway Management, Inc. · 2006
- This deviceK102521 Pantino Pro PositinerSomnomed, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −6 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −5 | K972061 | TOA | W. Keith Thornton, D.D.S. | 1997 | — |
| −4 | K022891 | The Breathe EZ Anti-Snoring Device | D&S Redhage | 2003 | — |
| −3 | K030440 | Oasys-Oral Airway System | Mark Abramson, D.D.S., Inc. | 2003 | — |
| −2 | K060388 | Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with Attachment | Airway Management, Inc. | 2006 | — |
| −1 | K061732 | TAP-T | Airway Management, Inc. | 2006 | — |
| 0 (this device) | K102521 | Pantino Pro Positiner | Somnomed, Inc. | 2011 | — |
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 |
| 2006 | 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…Device Information: Device Name Manufacturer 510(k) Reference IMAS RxA ISomnoMed Inc. K050592 TAP-T Airway Management Inc. K061732 TAP III AraM neent Inc.… | 2005 |
| * | K061732 | TAP-TSummary page 1…510(k) Reference IMAS RxA ISomnoMed Inc. K050592 TAP-T Airway Management Inc. K061732 TAP III AraM neent Inc. K062951 Device Description: The Pantino Pro Positioner is an… | 2006 |
| * | K062951 | Tap Iii Anti-Snoring DeviceSummary page 1…. K050592 TAP-T Airway Management Inc. K061732 TAP III AraM neent Inc. K062951 Device Description: The Pantino Pro Positioner is an intraoral device used for treating snoring and mild to moderate obstructiv… | 2006 |
| † | K073004 | Somnomed Bflex | 2008 |
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 22 years and passes through 7 companies; a new generation was cleared every 2.7 years on median.
- None of the 14 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. 2011, 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 Pantino Pro Positioner is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102521 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102521: Pantino Pro Positiner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102521
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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