# K091919: Devilbiss Intellipap/Sleepcube Bilevel S/ST

- Pathway: 510(k) (Traditional)
- Applicant: Sunrise Medical
- Decided: Sep 28, 2009 after 90 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- 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: 7 generations back to K971260 (1997). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 19 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.

## Most influential descendants
- K112220: Devilbiss Intellipap / Sleepcube Auto Bilevel (2011), 0 descendants of its own

## Recalls of this device
- May 13, 2014 · Class III · Z-1949-2014: A limited number of DV5x Series CPAP units were manufactured and shipped without the serial number programmed into the unit, causing the unit serial number on LCD display to appear as "RUN-TEST".

## Indications for use
The DeVilbiss IntelliPAP/SleepCube Model DV55 S Series 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/K091919
Methodology: https://510kreport.com/methodology