510(k) · Cleared
ClearedBongo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innomed Healthscience, Inc. · OHP Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea
Cleared on Aug 16, 2018 as substantially equivalent to K102404 (Ventus Medical, Inc., 2010) after a 160-day review. Its family tree reaches back 11 generations to 1996. 1 later device descends from it.
- Decided
- Aug 16, 2018
- Review
- 160 days
- Class
- Class II
- Product code
- OHP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K953930 (1996). 79 ancestors in all, the oldest K811102 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 7 generations between
- 3 generations backK071560 Provent Nasal Dilator, Model BR2Ventus Medical, Inc. · 2008
- 2 generations backK090398 Provent Professional Sleep Apnea TherapyVentus Medical, Inc. · 2009 · Recalled
- 1 generation backK102404 Provent Professional Sleep Apnea Therapy (Provent 80); Provent…Ventus Medical, Inc. · 2010
- This deviceK180619 BongoInnomed Healthscience, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK191728 ULTepap Expiratory Positive Airway Pressure (EPAP) DeviceBryggs Medical, LLC · 2020
Show all 11 generations
- Root · 11 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 10 generations backK993433 Virtuoso LX Smart Cpap SystemRespironics, Inc. · 1999
- 9 generations backK012554 Remstar Auto Cpap SystemRespironics, Inc. · 2002
- 8 generations backK031460 Modification to Remstar Auto Cpap SystemRespironics, Inc. · 2003
- 7 generations backK032834 Bipap Pro 2 BI-Level SystemRespironics, Inc. · 2004
- 6 generations backK043607 Bipap Pro 2 BI-Level System with BI-FlexRespironics, Inc. · 2005
- 5 generations backK050759 Bipap AutoRespironics, Inc. · 2005 · Recalled
- 4 generations backK063830 Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group · 2007
- 3 generations backK071560 Provent Nasal Dilator, Model BR2Ventus Medical, Inc. · 2008
- 2 generations backK090398 Provent Professional Sleep Apnea TherapyVentus Medical, Inc. · 2009 · Recalled
- 1 generation backK102404 Provent Professional Sleep Apnea Therapy (Provent 80); Provent…Ventus Medical, Inc. · 2010
- This deviceK180619 BongoInnomed Healthscience, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K191728ULTepap Expiratory Positive Airway Pressure (EPAP) DeviceBryggs Medical, LLC · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K953930 | Virtuoso Smart Cpap System | Respironics, Inc. | 1996 | — |
| −10 | K993433 | Virtuoso LX Smart Cpap System | Respironics, Inc. | 1999 | — |
| −9 | K012554 | Remstar Auto Cpap System | Respironics, Inc. | 2002 | — |
| −8 | K031460 | Modification to Remstar Auto Cpap System | Respironics, Inc. | 2003 | — |
| −7 | K032834 | Bipap Pro 2 BI-Level System | Respironics, Inc. | 2004 | — |
| −6 | K043607 | Bipap Pro 2 BI-Level System with BI-Flex | Respironics, Inc. | 2005 | — |
| −5 | K050759 | Bipap Auto | Respironics, Inc. | 2005 | 1 |
| −4 | K063830 | Remstar Aflex Cpap System | Respironics Inc., Sleep & Home Respiratory Group | 2007 | — |
| −3 | K071560 | Provent Nasal Dilator, Model BR2 | Ventus Medical, Inc. | 2008 | — |
| −2 | K090398 | Provent Professional Sleep Apnea Therapy | Ventus Medical, Inc. | 2009 | 1 |
| −1 | K102404 | Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional… | Ventus Medical, Inc. | 2010 | — |
| 0 (this device) | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K102404 | Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea…Summary page 4…n Name: 21CFR 872.5570 ProCode – OHP Class II Predicate Device: Ventus ProVent (K102404) Device Description: The Bongo intranasal appliance is a simple device which is placed just inside the nostrils. The device dire… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191728 | ULTepap Expiratory Positive Airway Pressure (EPAP) Device | 2020 | 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 22 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 14 of the 79 ancestors have a recall of any class.
- Of its descendants, K191728 (Bryggs Medical, LLC, 2020) has gone furthest, with 0 descendants of its own.
- 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. 2018, 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?
Bongo is indicated for use in the treatment of mild to moderate obstructive sleep apnea (OSA) in adults >66 lbs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180619 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180619: Bongo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180619
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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