# K091112: Respironics Sleepeasy Cpap System

- Pathway: 510(k) (Special)
- Applicant: Respironics, Inc.
- Decided: May 15, 2009 after 28 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: 4 generations back to K953930 (1996). 8 ancestors in all.
4 later devices descend from it; 1 cites it directly.
2 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010263: Remstar Plus Cpap System, Respironics, Inc. (2001) Summary page 1.
- K021861: Remstar Pro with C-Flex Cpap System, Respironics, Inc. (2002) Summary page 1.

## Most influential descendants
- K122769: Remstar SE (2012), 3 descendants of its own
- K130077: Remstar SE (2013), 2 descendants of its own
- K200480: DreamStation 2 System, DreamStation 2 Advanced System (2020), 1 descendant of its own
- K251770: SleepRes PAP System (2025), 0 descendants of its own

## Indications for use
The Respironics SleepEasy CPAP System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg. For use in the home or hospital/institutional environment

Source page: https://510kreport.com/device/K091112
Methodology: https://510kreport.com/methodology