510(k) · Cleared
ClearedRespire Blue Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respire Medical · LRK Device, Anti-Snoring
Cleared on Aug 23, 2011 as substantially equivalent to K060388 (Airway Management, Inc., 2006) and 3 other predicates after a 116-day review. Its family tree reaches back 6 generations to 1989. 11 later devices descend from it.
- Decided
- Aug 23, 2011
- Review
- 116 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K882303 (1989). 13 ancestors in all. 11 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 5 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 4 generations backK972061 TOAW. Keith Thornton, D.D.S. · 1997
- 3 generations backK022891 The Breathe EZ Anti-Snoring DeviceD&S Redhage · 2003
- 2 generations backK030440 Oasys-Oral Airway SystemMark Abramson, D.D.S., Inc. · 2003
- 1 generation backK060388 Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with…Airway Management, Inc. · 2006
- This deviceK111207 Respire Blue SeriesRespire Medical · 2011
- Descendant · cites it directly · 7 of its ownK131138 Respire Pink Series - HerbstRespire Medical · 2013
- Descendant · 2 generations on · 5 of its ownK150572 Respire Pink Series-Herbst-EFRespire Medical Holding · 2015 · Recalled
- Descendant · 2 generations on · 2 of its ownK170692 Respire Pink Series with DentiTracRespire Medical Holding · 2017
- Descendant · 3 generations on · 1 of its ownK192127 Respire Pink AT (Hard, Hard/Soft, EF)Respire Medical Holdings · 2020
- Descendant · 2 generations on · 0 of its ownK223624 Emerald HerbstIsland Dental Lab, Inc Dba Emerald Dental · 2023
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K131138Respire Pink Series - HerbstRespire Medical · 2013 · cites it directly7descendants
- K150572Respire Pink Series-Herbst-EFRespire Medical Holding · 2015 · 2 generations on5descendants
- K170692Respire Pink Series with DentiTracRespire Medical Holding · 2017 · 2 generations on2descendants
- K192127Respire Pink AT (Hard, Hard/Soft, EF)Respire Medical Holdings · 2020 · 3 generations on1descendant
- K223624Emerald HerbstIsland Dental Lab, Inc Dba Emerald Dental · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −5 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −4 | K972061 | TOA | W. Keith Thornton, D.D.S. | 1997 | — |
| −3 | K022891 | The Breathe EZ Anti-Snoring Device | D&S Redhage | 2003 | — |
| −2 | K030440 | Oasys-Oral Airway System | Mark Abramson, D.D.S., Inc. | 2003 | — |
| −1 | K060388 | Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with Attachment | Airway Management, Inc. | 2006 | — |
| 0 (this device) | K111207 | Respire Blue Series | Respire Medical | 2011 | — |
| +1 | K131138 | Respire Pink Series - Herbst | Respire Medical | 2013 | — |
| +2 | K150572 | Respire Pink Series-Herbst-EF | Respire Medical Holding | 2015 | 3 |
| +2 | K170692 | Respire Pink Series with DentiTrac | Respire Medical Holding | 2017 | — |
| +3 | K192127 | Respire Pink AT (Hard, Hard/Soft, EF) | Respire Medical Holdings | 2020 | — |
| +2 | K223624 | Emerald Herbst | Island Dental Lab, Inc Dba Emerald Dental | 2023 | — |
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 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 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? (4)
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 |
|---|---|---|---|
| * | K060388 | Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with AttachmentSummary page 1…fication Submission New Device 8 Identification of Legally Marketed Predicate Devices: Respire Blue Series is substantially equivalent to TAP 11K060388 ; Somnomed MAS K050592; Somnomed MAS Flex SK(073004 ;OASYS K(03044 in terms of intended use, indicati… | 2006 |
| * | K050592 | Somnomed Mas RxaSummary page 1…evice 8 Identification of Legally Marketed Predicate Devices: Respire Blue Series is substantially equivalent to TAP 11K060388 ; Somnomed MAS K050592; Somnomed MAS Flex SK(073004 ;OASYS K(03044 in terms of intended use, indication for use, technological characteris… | 2005 |
| * | K073004 | Somnomed BflexSummary page 3…_ _ _ _ _ _ _ _ K050592 K030440 K060388 K073004 Target population - Adults YES - YES YES YES YES… | 2008 |
| * | K030440 | Oasys-Oral Airway SystemSummary page 3…) _ _ _ _ _ _ _ _ K050592 K030440 K060388 K073004 Target population - Adults YES - YES YES YES… | 2003 |
What descends from it? (11)
See all 114 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 22 years and passes through 7 companies; a new generation was cleared every 5.3 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K131138 (Respire Medical, 2013) has gone furthest, with 7 descendants of its own.
- 3 other devices also cite its predicate K060388.
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 Respire Blue Series is indicated to treat mild to moderate OSA.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111207 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111207: Respire Blue Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111207
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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