# K090243: Remstar M-Series Auto with Aflex Cpap System

- Pathway: 510(k) (Special)
- Applicant: Respironics Inc., Sleep & Home Respiratory Group
- Decided: May 8, 2009 after 95 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: 8 generations back to K953930 (1996). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063830: Remstar Aflex Cpap System, Respironics Inc., Sleep & Home Respiratory Group (2007) Summary page 1.

## Indications for use
The Respironics REMstar M-Series Auto with AFLEX CPAP System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg.

Source page: https://510kreport.com/device/K090243
Methodology: https://510kreport.com/methodology