510(k) · Cleared
ClearedProvent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea Therapy (Provent 50)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ventus Medical, Inc. · OHP Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea
Cleared on Dec 2, 2010 as substantially equivalent to K071560 (Ventus Medical, Inc., 2008) and 1 other predicate after a 100-day review. Its family tree reaches back 10 generations to 1996. 2 later devices descend from it.
- Decided
- Dec 2, 2010
- Review
- 100 days
- Class
- Class II
- Product code
- OHP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K953930 (1996). 78 ancestors in all, the oldest K811102 (1981). 2 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 6 generations between
- 3 generations backK063830 Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group · 2007
- 2 generations backK071560 Provent Nasal Dilator, Model BR2Ventus Medical, Inc. · 2008
- 1 generation backK090398 Provent Professional Sleep Apnea TherapyVentus Medical, Inc. · 2009 · Recalled
- This deviceK102404 Provent Professional Sleep Apnea Therapy (Provent 80); Provent…Ventus Medical, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK180619 BongoInnomed Healthscience, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK191728 ULTepap Expiratory Positive Airway Pressure (EPAP) DeviceBryggs Medical, LLC · 2020
Show all 10 generations
- Root · 10 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 9 generations backK993433 Virtuoso LX Smart Cpap SystemRespironics, Inc. · 1999
- 8 generations backK012554 Remstar Auto Cpap SystemRespironics, Inc. · 2002
- 7 generations backK031460 Modification to Remstar Auto Cpap SystemRespironics, Inc. · 2003
- 6 generations backK032834 Bipap Pro 2 BI-Level SystemRespironics, Inc. · 2004
- 5 generations backK043607 Bipap Pro 2 BI-Level System with BI-FlexRespironics, Inc. · 2005
- 4 generations backK050759 Bipap AutoRespironics, Inc. · 2005 · Recalled
- 3 generations backK063830 Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group · 2007
- 2 generations backK071560 Provent Nasal Dilator, Model BR2Ventus Medical, Inc. · 2008
- 1 generation backK090398 Provent Professional Sleep Apnea TherapyVentus Medical, Inc. · 2009 · Recalled
- This deviceK102404 Provent Professional Sleep Apnea Therapy (Provent 80); Provent…Ventus Medical, Inc. · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K953930 | Virtuoso Smart Cpap System | Respironics, Inc. | 1996 | — |
| −9 | K993433 | Virtuoso LX Smart Cpap System | Respironics, Inc. | 1999 | — |
| −8 | K012554 | Remstar Auto Cpap System | Respironics, Inc. | 2002 | — |
| −7 | K031460 | Modification to Remstar Auto Cpap System | Respironics, Inc. | 2003 | — |
| −6 | K032834 | Bipap Pro 2 BI-Level System | Respironics, Inc. | 2004 | — |
| −5 | K043607 | Bipap Pro 2 BI-Level System with BI-Flex | Respironics, Inc. | 2005 | — |
| −4 | K050759 | Bipap Auto | Respironics, Inc. | 2005 | 1 |
| −3 | K063830 | Remstar Aflex Cpap System | Respironics Inc., Sleep & Home Respiratory Group | 2007 | — |
| −2 | K071560 | Provent Nasal Dilator, Model BR2 | Ventus Medical, Inc. | 2008 | — |
| −1 | K090398 | Provent Professional Sleep Apnea Therapy | Ventus Medical, Inc. | 2009 | 1 |
| 0 (this device) | K102404 | Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional… | Ventus Medical, Inc. | 2010 | — |
| +1 | K180619 | Bongo | Innomed Healthscience, Inc. | 2018 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 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 OHP? 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 OHP device
- #1 K191728 ULTepap Expiratory Positive Airway Pressure…score 2.2 · 12 generations · no Class I recall
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 |
|---|---|---|---|
| * | K071560 | Provent Nasal Dilator, Model BR2Summary page 1…snoring and obstmuctive sleep apnea (21 CFR 872.5570) Product Code: OHP Predicate Devices: ProventTM Professional Sleep Apnea Therapy, K071560 ProventTM Professional Sleep Apnea Therapy, K090398 Device Description The PROVENT device is pl… | 2008 |
| * | K090398 | Provent Professional Sleep Apnea TherapySummary page 1…OHP Predicate Devices: ProventTM Professional Sleep Apnea Therapy, K071560 ProventTM Professional Sleep Apnea Therapy, K090398 Device Description The PROVENT device is placed just inside the nostrils. The device directs expiratory flow through selected… | 2009 |
What descends from it? (2)
2 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 14 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- 14 of the 78 ancestors have a recall of any class.
- Of its descendants, K180619 (Innomed Healthscience, Inc., 2018) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K071560.
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. 2010, 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?
The PROVENT® Sleep Apnea Therapy Device is indicated for use in the treatment of obstructive sleep apnea (OSA).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102404 · printed Nov 3, 2026
Cite this page
510(k) Report. “K102404: Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea Therapy (Provent 50).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K102404
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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