# K150365: Cloud9 System

- Pathway: 510(k) (Traditional)
- Applicant: Insleep Technologies, LLC
- Decided: Jul 21, 2015 after 159 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- 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 K903764 (1990). 52 ancestors in all.
No later device cites it as a predicate yet.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100121: Model 300157 Cpap System, Aeiomed, Inc. (2010) Summary page 5.
- K132013: Swift Air, Resmed, Ltd. (2013) Summary page 5.

## Indications for use
The Cloud9® System is indicated for use by adults to reduce or eliminate simple snoring. The Cloud9® System maintains a continuous, positive low-pressure in the airway. The device is designed for prescription home use.

Source page: https://510kreport.com/device/K150365
Methodology: https://510kreport.com/methodology