# K093070: Devilbiss Intellipap/ Sleepcube Bilevel ST, DV56 ST Series

- Pathway: 510(k) (Traditional)
- Applicant: Sunrise Medical
- Decided: Jan 26, 2010 after 118 days
- Product code: MNS (Ventilator, Continuous, Non-Life-Supporting)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K971260 (1997). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080131: Vpap ST, Resmed, Ltd. (2008) Summary page 1.
- K032056: Bilevel Cpap, Model 9055 Series, Sunrise Medical (2004) Summary page 1.
- K071689: Devilbiss Intellipap Model DV 5 Series, Sunrise Medical (2007) Summary page 1.

## Indications for use
The DeVilbiss IntelliPAPISleep~ube Model DV56 ST Series Bilevel is intended for use in treating OSA in spontaneously breathing patients 30 Kg and above by means of application of positive air pressure. The Device is to be used in home and clinical environments.

Source page: https://510kreport.com/device/K093070
Methodology: https://510kreport.com/methodology