# K172335: Bleep DreamPort

- Pathway: 510(k) (Traditional)
- Applicant: Snapcpap
- Decided: Mar 30, 2018 after 240 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: 5 generations back to K982530 (1998). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073638: Swift LT, Resmed, Ltd. (2008) Summary page 4.

## Indications for use
The Bleep™ DreamPort nasal adhesive mask is intended to provide an interface from a Continuous Positive Airway Pressure (CPAP) or bi-level system. The mask to be used by adult patients (>66 lbs. / 30 kg.) for whom positive airway pressure has been prescribed. The mask is for single-patient reuse in the home, hospital/institutional environment.

Source page: https://510kreport.com/device/K172335
Methodology: https://510kreport.com/methodology