510(k) · Cleared
ClearedRespire Pink AT (Hard, Hard/Soft, EF)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respire Medical Holdings · LRK Device, Anti-Snoring
Cleared on Feb 5, 2020 as substantially equivalent to K150572 (Respire Medical Holding, 2015) after a 183-day review. Its family tree reaches back 9 generations to 1989. 1 later device descends from it.
- Decided
- Feb 5, 2020
- Review
- 183 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K882303 (1989). 18 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 5 generations between
- 3 generations backK111207 Respire Blue SeriesRespire Medical · 2011
- 2 generations backK131138 Respire Pink Series - HerbstRespire Medical · 2013
- 1 generation backK150572 Respire Pink Series-Herbst-EFRespire Medical Holding · 2015 · Recalled
- This deviceK192127 Respire Pink AT (Hard, Hard/Soft, EF)Respire Medical Holdings · 2020
- Descendant · cites it directly · 0 of its ownK214096 Respire ClearRespire Medical, LLC · 2022
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 backK111207 Respire Blue SeriesRespire Medical · 2011
- 2 generations backK131138 Respire Pink Series - HerbstRespire Medical · 2013
- 1 generation backK150572 Respire Pink Series-Herbst-EFRespire Medical Holding · 2015 · Recalled
- This deviceK192127 Respire Pink AT (Hard, Hard/Soft, EF)Respire Medical Holdings · 2020
Most influential descendants
Showing 1 of 1 · See all- K214096Respire ClearRespire Medical, LLC · 2022 · cites it directly0descendants
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 | K111207 | Respire Blue Series | Respire Medical | 2011 | — |
| −2 | K131138 | Respire Pink Series - Herbst | Respire Medical | 2013 | — |
| −1 | K150572 | Respire Pink Series-Herbst-EF | Respire Medical Holding | 2015 | 3 |
| 0 (this device) | K192127 | Respire Pink AT (Hard, Hard/Soft, EF) | Respire Medical Holdings | 2020 | — |
| +1 | K214096 | Respire Clear | Respire Medical, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (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 |
|---|---|---|---|
| * | K150572 | Respire Pink Series-Herbst-EFSummary page 4…Class II – Device Anti-Snoring Panel: Dental Product Code: LRK Predicate Device: K150572 - Respire Pink Series-Herbst-EF Indication for Use: Our devices are indicated to treat mild to moderate… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K214096 | Respire Clear | 2022 | 0 |
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 31 years and passes through 9 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 18 ancestors has a recall of any class.
- Of its descendants, K214096 (Respire Medical, LLC, 2022) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K150572.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
Our devices are indicated to treat mild to moderate Obstructive Sleep Apnea (OSA) in patients, 18 years of age or older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192127 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192127: Respire Pink AT (Hard, Hard/Soft, EF).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192127
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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