# K090398: Provent Professional Sleep Apnea Therapy

- Pathway: 510(k) (Traditional)
- Applicant: Ventus Medical, Inc.
- Decided: Apr 3, 2009 after 45 days
- Product code: OHP (Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea)
- Device class: 2
- Regulation: 21 CFR 872.5570
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K953930 (1996). 77 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071560: Provent Nasal Dilator, Model BR2, Ventus Medical, Inc. (2008) Summary page 1.

## Most influential descendants
- K102404: Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea Therapy (Provent 50) (2010), 2 descendants of its own
- K180619: Bongo (2018), 1 descendant of its own
- K191728: ULTepap Expiratory Positive Airway Pressure (EPAP) Device (2020), 0 descendants of its own

## Recalls of this device
- Feb 3, 2012 · Not classified · Z-1033-2012: A discrepancy was found during inspection of a returned unit that the lot number and SKU on cartoon did not match.

## Indications for use
The PROVENT Professional Sleep Apnea Therapy Device - PROVENT 50 intended use is for the treatment of obstructive sleep apnea (OSA).

Source page: https://510kreport.com/device/K090398
Methodology: https://510kreport.com/methodology