510(k) · Cleared

Cleared

Provent Nasal Dilator, Model BR2

K071560510(k) TraditionalCleared Feb 8, 2008246-day reviewClass II21 CFR 872.5570

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ventus Medical, Inc. · OHP Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea

Cleared on Feb 8, 2008 as substantially equivalent to K030440 (Mark Abramson, D.D.S., Inc., 2003) and 8 other predicates after a 246-day review. Its family tree reaches back 8 generations to 1996. 10 later devices descend from it.

Decided: Feb 8, 2008
Review: 246 days
Class: Class II
Product code: OHP
Recalls: None
Predicates: 9

Its longest line of descent runs back 8 generations to K953930 (1996). 76 ancestors in all, the oldest K811102 (1981). 10 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 8 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
7 generations backK993433 Virtuoso LX Smart Cpap SystemRespironics, Inc. · 1999
6 generations backK012554 Remstar Auto Cpap SystemRespironics, Inc. · 2002
5 generations backK031460 Modification to Remstar Auto Cpap SystemRespironics, Inc. · 2003
4 generations backK032834 Bipap Pro 2 BI-Level SystemRespironics, Inc. · 2004
3 generations backK043607 Bipap Pro 2 BI-Level System with BI-FlexRespironics, Inc. · 2005
2 generations backK050759 Bipap AutoRespironics, Inc. · 2005 · Recalled
1 generation backK063830 Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group · 2007
This deviceK071560 Provent Nasal Dilator, Model BR2Ventus Medical, Inc. · 2008
Descendant · cites it directly · 5 of its ownK111549 Attune Sleep Apnea SystemApnicure, Inc. · 2012
Descendant · 2 generations on · 3 of its ownK122130 Winx Sleep Therapy SystemApnicure, Inc. · 2012
Descendant · cites it directly · 3 of its ownK090398 Provent Professional Sleep Apnea TherapyVentus Medical, Inc. · 2009 · Recalled
Descendant · 2 generations on · 2 of its ownK130538 Winx Sleep Therapy SystemApnicure, Inc. · 2013
Descendant · cites it directly · 2 of its ownK102404 Provent Professional Sleep Apnea Therapy (Provent 80); Provent…Ventus Medical, Inc. · 2010

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2009high 2 (2012) · low 0 (2011)2026

Most influential descendants

Showing 5 of 10 · See all

K111549Attune Sleep Apnea SystemApnicure, Inc. · 2012 · cites it directly5descendants
K122130Winx Sleep Therapy SystemApnicure, Inc. · 2012 · 2 generations on3descendants
K090398Provent Professional Sleep Apnea TherapyVentus Medical, Inc. · 2009 · cites it directly3descendants
K130538Winx Sleep Therapy SystemApnicure, Inc. · 2013 · 2 generations on2descendants
K102404Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea…Ventus Medical, Inc. · 2010 · cites it directly2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−8	K953930	Virtuoso Smart Cpap System	Respironics, Inc.	1996	—
−7	K993433	Virtuoso LX Smart Cpap System	Respironics, Inc.	1999	—
−6	K012554	Remstar Auto Cpap System	Respironics, Inc.	2002	—
−5	K031460	Modification to Remstar Auto Cpap System	Respironics, Inc.	2003	—
−4	K032834	Bipap Pro 2 BI-Level System	Respironics, Inc.	2004	—
−3	K043607	Bipap Pro 2 BI-Level System with BI-Flex	Respironics, Inc.	2005	—
−2	K050759	Bipap Auto	Respironics, Inc.	2005	1
−1	K063830	Remstar Aflex Cpap System	Respironics Inc., Sleep & Home Respiratory Group	2007	—
0 (this device)	K071560	Provent Nasal Dilator, Model BR2	Ventus Medical, Inc.	2008	—
+1	K111549	Attune Sleep Apnea System	Apnicure, Inc.	2012	—
+2	K122130	Winx Sleep Therapy System	Apnicure, Inc.	2012	—
+1	K090398	Provent Professional Sleep Apnea Therapy	Ventus Medical, Inc.	2009	1
+2	K130538	Winx Sleep Therapy System	Apnicure, Inc.	2013	—
+1	K102404	Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional…	Ventus Medical, Inc.	2010	—

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
2009	1	0
2010	1	0
2012	2	0
2013	1	0
2014	1	0
2018	1	0
2020	2	0
2023	1	0

FIG. 1 — Lineage of K071560, 1996–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (9)

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	Applicant	Decided	Recalls
*	K030440	Oasys-Oral Airway System Summary page 1 …ed in the 510(k) Notification are noted in the below table of comparison to predicate devices. A few examples are cited below. o @ o _ o o o Oasys Oral Airway System, K030440 REMstar Auto M-Series with AFLEX Series CPAP System (K063830) Breas iSleep 20i System (K063476) BiPAP Synchrony (K071509, K0703…	Mark Abramson, D.D.S., Inc.	2003	—
*	K063830	Remstar Aflex Cpap System Summary page 1 …comparison to predicate devices. A few examples are cited below. o @ o _ o o o Oasys Oral Airway System, K030440 REMstar Auto M-Series with AFLEX Series CPAP System (K063830) Breas iSleep 20i System (K063476) BiPAP Synchrony (K071509, K070328, K063533) BiPAP Auto SV (K063540) BiPAP Focus (K053168)…	Respironics Inc., Sleep & Home Respiratory Group	2007	—
*	K063476	Breas Isleep 20I Summary page 1 …few examples are cited below. o @ o _ o o o Oasys Oral Airway System, K030440 REMstar Auto M-Series with AFLEX Series CPAP System (K063830) Breas iSleep 20i System (K063476) BiPAP Synchrony (K071509, K070328, K063533) BiPAP Auto SV (K063540) BiPAP Focus (K053168) 10-1 24 Device De…	Breas Medical AB	2007	—
*	K071509	Bipap Synchrony 2 Ventilatory Support System Cleared while this submission was under review Summary page 1 …low. o @ o _ o o o Oasys Oral Airway System, K030440 REMstar Auto M-Series with AFLEX Series CPAP System (K063830) Breas iSleep 20i System (K063476) BiPAP Synchrony (K071509, K070328, K063533) BiPAP Auto SV (K063540) BiPAP Focus (K053168) 10-1 24 Device Description The Provent devi…	Respironics Inc., Sleep & Home Respiratory Group	2007	2
*	K070328	Bipap Synchrony with Avaps Summary page 1 …o _ o o o Oasys Oral Airway System, K030440 REMstar Auto M-Series with AFLEX Series CPAP System (K063830) Breas iSleep 20i System (K063476) BiPAP Synchrony (K071509, K070328, K063533) BiPAP Auto SV (K063540) BiPAP Focus (K053168) 10-1 24 Device Description The Provent device is pla…	Respironics Inc., Sleep & Home Respiratory Group	2007	—
*	K063533	Bipap Synchrony Summary page 1 …o Oasys Oral Airway System, K030440 REMstar Auto M-Series with AFLEX Series CPAP System (K063830) Breas iSleep 20i System (K063476) BiPAP Synchrony (K071509, K070328, K063533) BiPAP Auto SV (K063540) BiPAP Focus (K053168) 10-1 24 Device Description The Provent device is placed just…	Respironics, Inc.	2007	—
*	K063540	Bipap Autosv Summary page 1 …em, K030440 REMstar Auto M-Series with AFLEX Series CPAP System (K063830) Breas iSleep 20i System (K063476) BiPAP Synchrony (K071509, K070328, K063533) BiPAP Auto SV (K063540) BiPAP Focus (K053168) 10-1 24 Device Description The Provent device is placed just inside the nostrils. The…	Respironics, Inc.	2007	—
*	K053168	Bipap Focus Summary page 1 …to M-Series with AFLEX Series CPAP System (K063830) Breas iSleep 20i System (K063476) BiPAP Synchrony (K071509, K070328, K063533) BiPAP Auto SV (K063540) BiPAP Focus (K053168) 10-1 24 Device Description The Provent device is placed just inside the nostrils. The device directs expirat…	Respironics (Ireland) Limited	2006	1
*	K983920	Ems Peep Valves- Adjustable Summary page 2 …s predicates. Intraoral devices, cervical .pillows, CPAP/BIiPAP Oasys Oral devices and Airway EMS PEEP accessories, Provent System, Vaives, RF, and laser Device KO30440 K983920 devices Indications \| The Provent \| The OASYS \| An accessory As noted in for Use device is Oral Airway to provide above tables, i…	Engineered Medical Systems	1999	—

Also cleared against K030440: 5 other devices →

What descends from it? (10)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K111549	Attune Sleep Apnea System	Apnicure, Inc.	2012	5
K090398	Provent Professional Sleep Apnea Therapy	Ventus Medical, Inc.	2009	3
K102404	Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea…	Ventus Medical, Inc.	2010	2

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 12 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
13 of the 76 ancestors have a recall of any class.
Of its descendants, K111549 (Apnicure, Inc., 2012) has gone furthest, with 5 descendants of its own.
5 other devices also cite its predicate K030440.

How does its category compare?

All OHP devices

OHP Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · OHP

1in 2020

2007high 1 (2008) · low 0 (2007)2026

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

2007high 1 (2012) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OHP

1in 2017

2007high 1 (2012) · low 0 (2007)2025

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™ Professional Sleep Apnea Therapy device is indicated for use in the treatment of obstructive sleep apnea (OSA).

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K071560 · printed Nov 5, 2026

Cite this page

510(k) Report. “K071560: Provent Nasal Dilator, Model BR2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071560

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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