# K041010: Remstar Auto with C-Flex Cpap System

- Pathway: 510(k) (Special)
- Applicant: Respironics, Inc.
- Decided: May 5, 2004 after 15 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K953930 (1996). 6 ancestors in all.
40 later devices descend from it; 2 cite it directly.
12 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012554: Remstar Auto Cpap System, Respironics, Inc. (2002) Summary page 1.
- K031460: Modification to Remstar Auto Cpap System, Respironics, Inc. (2003) Summary page 1.

## Most influential descendants
- K050759: Bipap Auto (2005), 37 descendants of its own
- K063830: Remstar Aflex Cpap System (2007), 35 descendants of its own
- K091319: Remstar Auto a-Flex (2009), 22 descendants of its own
- K092818: Bipap Avaps Ventilatory Support System (2010), 11 descendants of its own
- K071560: Provent Nasal Dilator, Model BR2 (2008), 10 descendants of its own

## Recalls of this device
- Oct 15, 2007 · Not classified · Z-1064-2008: Foreign material: Glass fragments may present in the plastic bag material used to ship components.
- Oct 15, 2007 · Not classified · Z-1065-2008: Foreign material: Glass fragments may present in the plastic bag material used to ship components.
- Oct 15, 2007 · Not classified · Z-1083-2008: Foreign material: Glass fragments may present in the plastic bag material used to ship components.

## Indications for use
The REMstar Auto with C-Flex CPAP System is a CPAP (Continuous Positive Airway Pressure) device designed for the treatment of adult Obstructive Sleep Apnea (OSA) only. The device is for use in the home or hospital/institutional environment.

Source page: https://510kreport.com/device/K041010
Methodology: https://510kreport.com/methodology