510(k) · Cleared
ClearedULTepap Expiratory Positive Airway Pressure (EPAP) Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bryggs Medical, LLC · OHP Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea
Cleared on Feb 21, 2020 as substantially equivalent to K102404 (Ventus Medical, Inc., 2010) and 1 other predicate after a 239-day review. Its family tree reaches back 12 generations to 1996.
- Decided
- Feb 21, 2020
- Review
- 239 days
- Class
- Class II
- Product code
- OHP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K953930 (1996). 80 ancestors in all, the oldest K811102 (1981). No later device cites it as a predicate yet.
- Root · 12 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 8 generations between
- 3 generations backK090398 Provent Professional Sleep Apnea TherapyVentus Medical, Inc. · 2009 · Recalled
- 2 generations backK102404 Provent Professional Sleep Apnea Therapy (Provent 80); Provent…Ventus Medical, Inc. · 2010
- 1 generation backK180619 BongoInnomed Healthscience, Inc. · 2018
- This deviceK191728 ULTepap Expiratory Positive Airway Pressure (EPAP) DeviceBryggs Medical, LLC · 2020
Show all 12 generations
- Root · 12 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 11 generations backK993433 Virtuoso LX Smart Cpap SystemRespironics, Inc. · 1999
- 10 generations backK012554 Remstar Auto Cpap SystemRespironics, Inc. · 2002
- 9 generations backK031460 Modification to Remstar Auto Cpap SystemRespironics, Inc. · 2003
- 8 generations backK032834 Bipap Pro 2 BI-Level SystemRespironics, Inc. · 2004
- 7 generations backK043607 Bipap Pro 2 BI-Level System with BI-FlexRespironics, Inc. · 2005
- 6 generations backK050759 Bipap AutoRespironics, Inc. · 2005 · Recalled
- 5 generations backK063830 Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group · 2007
- 4 generations backK071560 Provent Nasal Dilator, Model BR2Ventus Medical, Inc. · 2008
- 3 generations backK090398 Provent Professional Sleep Apnea TherapyVentus Medical, Inc. · 2009 · Recalled
- 2 generations backK102404 Provent Professional Sleep Apnea Therapy (Provent 80); Provent…Ventus Medical, Inc. · 2010
- 1 generation backK180619 BongoInnomed Healthscience, Inc. · 2018
- This deviceK191728 ULTepap Expiratory Positive Airway Pressure (EPAP) DeviceBryggs Medical, LLC · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K953930 | Virtuoso Smart Cpap System | Respironics, Inc. | 1996 | — |
| −11 | K993433 | Virtuoso LX Smart Cpap System | Respironics, Inc. | 1999 | — |
| −10 | K012554 | Remstar Auto Cpap System | Respironics, Inc. | 2002 | — |
| −9 | K031460 | Modification to Remstar Auto Cpap System | Respironics, Inc. | 2003 | — |
| −8 | K032834 | Bipap Pro 2 BI-Level System | Respironics, Inc. | 2004 | — |
| −7 | K043607 | Bipap Pro 2 BI-Level System with BI-Flex | Respironics, Inc. | 2005 | — |
| −6 | K050759 | Bipap Auto | Respironics, Inc. | 2005 | 1 |
| −5 | K063830 | Remstar Aflex Cpap System | Respironics Inc., Sleep & Home Respiratory Group | 2007 | — |
| −4 | K071560 | Provent Nasal Dilator, Model BR2 | Ventus Medical, Inc. | 2008 | — |
| −3 | K090398 | Provent Professional Sleep Apnea Therapy | Ventus Medical, Inc. | 2009 | 1 |
| −2 | K102404 | Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional… | Ventus Medical, Inc. | 2010 | — |
| −1 | K180619 | Bongo | Innomed Healthscience, Inc. | 2018 | — |
| 0 (this device) | K191728 | ULTepap Expiratory Positive Airway Pressure (EPAP) Device | Bryggs Medical, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 7 | 0 |
| 1997 | 6 | 0 |
| 1998 | 5 | 0 |
| 1999 | 6 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 7 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 5 | 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 OHP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K102404 | Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea…Summary page 5…ch The Device Is Substantially Equivalent The ULTepapTM is substantially equivalent to Ventus Medical’s Provent cleared under K102404 on December 2, 2010 and InnoMed Healthscience’s Bongo cleared under K180619 on August 16, 2018. BRYGGS is also introd… | 2010 |
| * | K180619 | BongoSummary page 5…e ULTepapTM is substantially equivalent to Ventus Medical’s Provent cleared under K102404 on December 2, 2010 and InnoMed Healthscience’s Bongo cleared under K180619 on August 16, 2018. BRYGGS is also introducing reference devices for the purpose of making some technolog… | 2018 |
| † | K034053 | TMS Snapp Soft Nasal Accessory for Positive Pressure, Models TMS-3020, TMS-3030 & TMS-3040 | 2004 |
| † | K900164 | Airway Delivery & Management (Adam) Nasal Ventila. | 1990 |
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 24 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 14 of the 80 ancestors have a recall of any class.
- 1 other device also cites its predicate K102404.
How does its category compare?
All OHP devicesOHP Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · OHP
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · OHP
Too few OHP 510(k)s in any year since 2007 to give a median.
Recalls per year · OHP
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OHP
1in 2017
MAUDE reports naming product code OHP, 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 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 1 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
ULTepap ™ is indicated for use in the treatment of mild to moderate Obstructive Sleep Apnea (OSA) in adults> 66lbs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191728 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191728: ULTepap Expiratory Positive Airway Pressure (EPAP) Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191728
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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