# K143677: DeVilbiss Intellipap2/DeVilbiss BLUE

- Pathway: 510(k) (Traditional)
- Applicant: Devilbiss Healthcare, LLC
- Decided: Sep 18, 2015 after 268 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: 10 generations back to K953930 (1996). 32 ancestors in all.
No later device cites it as a predicate yet.
2 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071689: Devilbiss Intellipap Model DV 5 Series, Sunrise Medical (2007) Summary page 4.
- K113068: Remstar Auto a-Flex HT, Respironics, Inc. (2011) Summary page 4.

## Indications for use
The DeVilbiss Intellipap2/DeVilbiss BLUE Series is intended for use in treating OSA in spontaneously breathing patients 30 Kg (66 lbs) and above by means of application of positive air pressure. The Device is to be used in Home and Healthcare Environments.

Source page: https://510kreport.com/device/K143677
Methodology: https://510kreport.com/methodology