# K200480: DreamStation 2 System, DreamStation 2 Advanced System

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Jul 10, 2020 after 134 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: 12 generations back to K953930 (1996). 35 ancestors in all.
1 later device descends from it; 1 cites it directly.
5 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131982: Remstar Auto a-Flex HT, Respironics, Inc. (2013) Summary page 4.
- K130077: Remstar SE, Respironics, Inc. (2013) Summary page 4.

## Most influential descendants
- K251770: SleepRes PAP System (2025), 0 descendants of its own

## Indications for use
The DreamStation 2 CPAP/DreamStation 2 Auto CPAP system delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30 kg (66 Ibs). It is for use in the home or hospital/institutional environment.

Source page: https://510kreport.com/device/K200480
Methodology: https://510kreport.com/methodology