510(k) · Cleared
ClearedSomnomed Bflex
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 Jan 30, 2008 as substantially equivalent to K050592 (Somnomed, Ltd., 2005) after a 98-day review. Its family tree reaches back 4 generations to 1989. 32 later devices descend from it.
- Decided
- Jan 30, 2008
- Review
- 98 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K882303 (1989). 5 ancestors in all. 32 later devices descend from it, 8 citing it directly.
- Root · 4 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 3 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 2 generations backK042161 Anti-Snoring/Sleep Apnea DeviceRj & VK Bird Pty, Ltd. · 2004
- 1 generation backK050592 Somnomed Mas RxaSomnomed, Ltd. · 2005
- This deviceK073004 Somnomed BflexSomnomed, Inc. · 2008
- Descendant · cites it directly · 18 of its ownK121340 Somnodent G2Somnomed, Inc. · 2012
- Descendant · cites it directly · 16 of its ownK130558 Somnodent Herbst; Classic, FlexSomnomed, Inc. · 2013
- Descendant · cites it directly · 14 of its ownK140278 Somnodent Fusion, Classic; Somnodent Fusion, FlexSomnomed, Inc. · 2014
- Descendant · 2 generations on · 12 of its ownK150369 SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with…Somnomed, Inc. · 2015
- Descendant · cites it directly · 11 of its ownK111207 Respire Blue SeriesRespire Medical · 2011
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K121340Somnodent G2Somnomed, Inc. · 2012 · cites it directly18descendants
- K130558Somnodent Herbst; Classic, FlexSomnomed, Inc. · 2013 · cites it directly16descendants
- K140278Somnodent Fusion, Classic; Somnodent Fusion, FlexSomnomed, Inc. · 2014 · cites it directly14descendants
- K150369SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac…Somnomed, Inc. · 2015 · 2 generations on12descendants
- K111207Respire Blue SeriesRespire Medical · 2011 · cites it directly11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −3 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −2 | K042161 | Anti-Snoring/Sleep Apnea Device | Rj & VK Bird Pty, Ltd. | 2004 | — |
| −1 | K050592 | Somnomed Mas Rxa | Somnomed, Ltd. | 2005 | — |
| 0 (this device) | K073004 | Somnomed Bflex | Somnomed, Inc. | 2008 | — |
| +1 | K121340 | Somnodent G2 | Somnomed, Inc. | 2012 | — |
| +1 | K130558 | Somnodent Herbst; Classic, Flex | Somnomed, Inc. | 2013 | — |
| +1 | K140278 | Somnodent Fusion, Classic; Somnodent Fusion, Flex | Somnomed, Inc. | 2014 | — |
| +2 | K150369 | SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac… | Somnomed, Inc. | 2015 | — |
| +1 | K111207 | Respire Blue Series | Respire Medical | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K050592 | Somnomed Mas RxaSummary page 1…edicate Device Information: Device Name Manufacturer 510(k)Reference SomnoMed MAS SomnoMed Inc K(050592 Device Description: The Somnomed MAS Flex "S" is an intra-oral device used for treating Snoring and mild to moderate Obstructive… | 2005 |
| † | K896130 | SR-Ivocap | 1990 |
What descends from it? (32)
See all 328 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121340 | Somnodent G2 | 2012 | 18 |
| K130558 | Somnodent Herbst; Classic, Flex | 2013 | 16 |
| K140278 | Somnodent Fusion, Classic; Somnodent Fusion, Flex | 2014 | 14 |
| K111207 | Respire Blue Series | 2011 | 11 |
| K183443 | SomnoDent Avant | 2019 | 2 |
| K181416 | Sapphire Dorsal Comfort Fit | 2019 | 0 |
| K121344 | NU Sleep | 2012 | 0 |
| K090436 | Airwayease Mas | 2010 | 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 19 years and passes through 5 companies; a new generation was cleared every 7.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K121340 (Somnomed, Inc., 2012) has gone furthest, with 18 descendants of its own.
- 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. 2008, 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 SomnoMed MAS Flex "S" is intended to reduce or alleviate night time Snoring and
mild to moderate Obstructive Sleep Apnea (OSA).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073004 · printed Nov 5, 2026
Cite this page
510(k) Report. “K073004: Somnomed Bflex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K073004
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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