# K112220: Devilbiss Intellipap / Sleepcube Auto Bilevel

- Pathway: 510(k) (Traditional)
- Applicant: Devilbiss Healthcare, LLC
- Decided: Nov 22, 2011 after 112 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: 8 generations back to K971260 (1997). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082605: Vpap Auto with Humidaire 3I, Resmed, Ltd. (2009) Summary page 3.
- K091919: Devilbiss Intellipap/Sleepcube Bilevel S/ST, Sunrise Medical (2009) Summary page 3.
- K071689: Devilbiss Intellipap Model DV 5 Series, Sunrise Medical (2007) Summary page 1.

## 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 lntelliPAP/SleepCube Model DV57 Series Auto 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/K112220
Methodology: https://510kreport.com/methodology