# K071689: Devilbiss Intellipap Model DV 5 Series

- Pathway: 510(k) (Traditional)
- Applicant: Sunrise Medical
- Decided: Sep 7, 2007 after 79 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 4 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K091919: Devilbiss Intellipap/Sleepcube Bilevel S/ST (2009), 1 descendant of its own
- K143677: DeVilbiss Intellipap2/DeVilbiss BLUE (2015), 0 descendants of its own
- K112220: Devilbiss Intellipap / Sleepcube Auto Bilevel (2011), 0 descendants of its own
- K093070: Devilbiss Intellipap/ Sleepcube Bilevel ST, DV56 ST Series (2010), 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".
- Mar 11, 2011 · Not classified · Z-2990-2011: Some units were manufactured with a defective humidifier chamber o-ring. Unit could leak, allowing water to escape during use, causing damage to furniture.

## Indications for use
The DeVilbiss IntelliPAP Model DV5 Series is intended for use in treating obstructive sleep apnea in patients 30 Kg and above.

Source page: https://510kreport.com/device/K071689
Methodology: https://510kreport.com/methodology