# K180619: Bongo

- Pathway: 510(k) (Traditional)
- Applicant: Innomed Healthscience, Inc.
- Decided: Aug 16, 2018 after 160 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: 11 generations back to K953930 (1996). 79 ancestors in all.
1 later device descends 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)
- K102404: Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea Therapy (Provent 50), Ventus Medical, Inc. (2010) Summary page 4.

## Most influential descendants
- K191728: ULTepap Expiratory Positive Airway Pressure (EPAP) Device (2020), 0 descendants of its own

## Indications for use
Bongo is indicated for use in the treatment of mild to moderate obstructive sleep apnea (OSA) in adults >66 lbs.

Source page: https://510kreport.com/device/K180619
Methodology: https://510kreport.com/methodology