# K071560: Provent Nasal Dilator, Model BR2

- Pathway: 510(k) (Traditional)
- Applicant: Ventus Medical, Inc.
- Decided: Feb 8, 2008 after 246 days
- Product code: OHP (Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea)
- Device class: 2
- Regulation: 21 CFR 872.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K953930 (1996). 76 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030440: Oasys-Oral Airway System, Mark Abramson, D.D.S., Inc. (2003) Summary page 1.
- K063830: Remstar Aflex Cpap System, Respironics Inc., Sleep & Home Respiratory Group (2007) Summary page 1.
- K063476: Breas Isleep 20I, Breas Medical AB (2007) Summary page 1.
- K071509: Bipap Synchrony 2 Ventilatory Support System, Respironics Inc., Sleep & Home Respiratory Group (2007). Cleared while this submission was under review Summary page 1.
- K070328: Bipap Synchrony with Avaps, Respironics Inc., Sleep & Home Respiratory Group (2007) Summary page 1.
- K063533: Bipap Synchrony, Respironics, Inc. (2007) Summary page 1.
- K063540: Bipap Autosv, Respironics, Inc. (2007) Summary page 1.
- K053168: Bipap Focus, Respironics (Ireland) Limited (2006) Summary page 1.
- K983920: Ems Peep Valves- Adjustable, Engineered Medical Systems (1999) Summary page 2.

## Most influential descendants
- K111549: Attune Sleep Apnea System (2012), 5 descendants of its own
- K122130: Winx Sleep Therapy System (2012), 3 descendants of its own
- K090398: Provent Professional Sleep Apnea Therapy (2009), 3 descendants of its own
- K130538: Winx Sleep Therapy System (2013), 2 descendants of its own
- K102404: Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea Therapy (Provent 50) (2010), 2 descendants of its own

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

Source page: https://510kreport.com/device/K071560
Methodology: https://510kreport.com/methodology