510(k) · Cleared
ClearedRespire Pink Series with DentiTrac
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respire Medical Holding · LRK Device, Anti-Snoring
Cleared on May 26, 2017 as substantially equivalent to K150369 (Somnomed, Inc., 2015) and 2 other predicates after an 80-day review. Its family tree reaches back 9 generations to 1989. 2 later devices descend from it.
- Decided
- May 26, 2017
- Review
- 80 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K882303 (1989). 22 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 5 generations between
- 3 generations backK130558 Somnodent Herbst; Classic, FlexSomnomed, Inc. · 2013
- 2 generations backK140278 Somnodent Fusion, Classic; Somnodent Fusion, FlexSomnomed, Inc. · 2014
- 1 generation backK150369 SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with…Somnomed, Inc. · 2015
- This deviceK170692 Respire Pink Series with DentiTracRespire Medical Holding · 2017
- Descendant · cites it directly · 0 of its ownK223624 Emerald HerbstIsland Dental Lab, Inc Dba Emerald Dental · 2023
- Descendant · cites it directly · 0 of its ownK190353 Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with…Residential Home Sleep Services · 2020
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 backK042161 Anti-Snoring/Sleep Apnea DeviceRj & VK Bird Pty, Ltd. · 2004
- 6 generations backK050592 Somnomed Mas RxaSomnomed, Ltd. · 2005
- 5 generations backK073004 Somnomed BflexSomnomed, Inc. · 2008
- 4 generations backK121340 Somnodent G2Somnomed, Inc. · 2012
- 3 generations backK130558 Somnodent Herbst; Classic, FlexSomnomed, Inc. · 2013
- 2 generations backK140278 Somnodent Fusion, Classic; Somnodent Fusion, FlexSomnomed, Inc. · 2014
- 1 generation backK150369 SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with…Somnomed, Inc. · 2015
- This deviceK170692 Respire Pink Series with DentiTracRespire Medical Holding · 2017
Most influential descendants
Showing 2 of 2 · See allView 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 | K042161 | Anti-Snoring/Sleep Apnea Device | Rj & VK Bird Pty, Ltd. | 2004 | — |
| −6 | K050592 | Somnomed Mas Rxa | Somnomed, Ltd. | 2005 | — |
| −5 | K073004 | Somnomed Bflex | Somnomed, Inc. | 2008 | — |
| −4 | K121340 | Somnodent G2 | Somnomed, Inc. | 2012 | — |
| −3 | K130558 | Somnodent Herbst; Classic, Flex | Somnomed, Inc. | 2013 | — |
| −2 | K140278 | Somnodent Fusion, Classic; Somnodent Fusion, Flex | Somnomed, Inc. | 2014 | — |
| −1 | K150369 | SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac… | Somnomed, Inc. | 2015 | — |
| 0 (this device) | K170692 | Respire Pink Series with DentiTrac | Respire Medical Holding | 2017 | — |
| +1 | K223624 | Emerald Herbst | Island Dental Lab, Inc Dba Emerald Dental | 2023 | — |
| +1 | K190353 | Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac | Residential Home Sleep Services | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2003 | 3 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K150369 | SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac…Summary page 4…Predicate Manufacturer 510(k) Number SomnoDent® with Micro-Recorder SomnoMed, Inc. K150369 Respire Pink Series Respire Pink Series-Herbst Respire Medical, LLC K131138 with Denti… | 2015 |
| * | K131138 | Respire Pink Series - HerbstSummary page 4…® with Micro-Recorder SomnoMed, Inc. K150369 Respire Pink Series Respire Pink Series-Herbst Respire Medical, LLC K131138 with DentiTrac® Respire Pink Series-Herbst-EF Respire Medical, LLC K150572 The primary pre… | 2013 |
| * | K150572 | Respire Pink Series-Herbst-EFSummary page 4…re Pink Series-Herbst Respire Medical, LLC K131138 with DentiTrac® Respire Pink Series-Herbst-EF Respire Medical, LLC K150572 The primary predicate device used for substantial equivalence is the SomnoMed SomnoDent® with Micro-Recorder. The reference pred… | 2015 |
What descends from it? (2)
2 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 28 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 22 ancestors has a recall of any class.
- Of its descendants, K223624 (Island Dental Lab, Inc Dba Emerald Dental, 2023) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K150369.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Respire Pink Series intraoral appliances are intended to treat snoring and mild to moderate Obstructive Sleep Apnea (OSA) in adult patients 18 years of age or older.
Optionally, the DentiTrac® micro-recorder may be incorporated into a Respire Pink Series device. The micro-recorder is intended to measure patient compliance to oral appliance therapy in combination with the DentiTrac® system.
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/K170692 · printed Nov 4, 2026
Cite this page
510(k) Report. “K170692: Respire Pink Series with DentiTrac.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K170692
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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