510(k) · Cleared
ClearedBfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Residential Home Sleep Services · PLC Sleep Appliances With Patient Monitoring
Cleared on Apr 10, 2020 as substantially equivalent to K170692 (Respire Medical Holding, 2017) and 1 other predicate after a 420-day review. Its family tree reaches back 10 generations to 1989.
- Decided
- Apr 10, 2020
- Review
- 420 days
- Class
- Class II
- Product code
- PLC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K882303 (1989). 28 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 6 generations between
- 3 generations backK140278 Somnodent Fusion, Classic; Somnodent Fusion, FlexSomnomed, Inc. · 2014
- 2 generations backK150369 SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with…Somnomed, Inc. · 2015
- 1 generation backK170692 Respire Pink Series with DentiTracRespire Medical Holding · 2017
- This deviceK190353 Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with…Residential Home Sleep Services · 2020
Show all 10 generations
- Root · 10 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 9 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 8 generations backK042161 Anti-Snoring/Sleep Apnea DeviceRj & VK Bird Pty, Ltd. · 2004
- 7 generations backK050592 Somnomed Mas RxaSomnomed, Ltd. · 2005
- 6 generations backK073004 Somnomed BflexSomnomed, Inc. · 2008
- 5 generations backK121340 Somnodent G2Somnomed, Inc. · 2012
- 4 generations backK130558 Somnodent Herbst; Classic, FlexSomnomed, Inc. · 2013
- 3 generations backK140278 Somnodent Fusion, Classic; Somnodent Fusion, FlexSomnomed, Inc. · 2014
- 2 generations backK150369 SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with…Somnomed, Inc. · 2015
- 1 generation backK170692 Respire Pink Series with DentiTracRespire Medical Holding · 2017
- This deviceK190353 Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with…Residential Home Sleep Services · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −9 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −8 | K042161 | Anti-Snoring/Sleep Apnea Device | Rj & VK Bird Pty, Ltd. | 2004 | — |
| −7 | K050592 | Somnomed Mas Rxa | Somnomed, Ltd. | 2005 | — |
| −6 | K073004 | Somnomed Bflex | Somnomed, Inc. | 2008 | — |
| −5 | K121340 | Somnodent G2 | Somnomed, Inc. | 2012 | — |
| −4 | K130558 | Somnodent Herbst; Classic, Flex | Somnomed, Inc. | 2013 | — |
| −3 | 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 | K170692 | Respire Pink Series with DentiTrac | Respire Medical Holding | 2017 | — |
| 0 (this device) | 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 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 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 PLC? 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 PLC device
- #1 K252765 ProSomnus RPMO2 OSA Device (RPMO2 OSA)score 17.1 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K170692 | Respire Pink Series with DentiTracSummary page 4…ulation Number 872.5570 Panel Dental Predicate Devices Primary Predicate Device: Respire Pink Series with DentiTrac, K170692 Reference Device: ASD Elastic, K163580 Intended Use/Indications for The BFit Intraoral Applian… | 2017 |
| * | K163580 | ASD Oral AppliancesSummary page 4…ntal Predicate Devices Primary Predicate Device: Respire Pink Series with DentiTrac, K170692 Reference Device: ASD Elastic, K163580 Intended Use/Indications for The BFit Intraoral Appliances are likely to reduce snoring and mild to Use… | 2017 |
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 31 years and passes through 7 companies; a new generation was cleared every 2.6 years on median.
- 2 of the 28 ancestors have a recall of any class.
- 1 other device also cites its predicate K170692.
How does its category compare?
All PLC devicesPLC Sleep Appliances With Patient Monitoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · PLC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PLC
Too few PLC 510(k)s in any year since 2007 to give a median.
Recalls per year · PLC
No recall names PLC since 2007.
Adverse event reports per year · PLC
1in 2023
MAUDE reports naming product code PLC, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 2 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The BFit Intraoral Appliances are likely to reduce 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 the Bfit device. The DentiTrac is intended to measure patient compliance to oral appliance therapy in combination with the DentiTrac System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190353 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190353: Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190353
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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