# K031460: Modification to Remstar Auto Cpap System

- Pathway: 510(k) (Special)
- Applicant: Respironics, Inc.
- Decided: Jun 24, 2003 after 47 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: 3 generations back to K953930 (1996). 5 ancestors in all.
74 later devices descend from it; 3 cite it directly.
12 of 80 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)
- K993433: Virtuoso LX Smart Cpap System, Respironics, Inc. (1999) Summary page 1.

## Most influential descendants
- K041010: Remstar Auto with C-Flex Cpap System (2004), 40 descendants of its own
- K032834: Bipap Pro 2 BI-Level System (2004), 40 descendants of its own
- K043607: Bipap Pro 2 BI-Level System with BI-Flex (2005), 39 descendants of its own
- K050759: Bipap Auto (2005), 37 descendants of its own
- K063830: Remstar Aflex Cpap System (2007), 35 descendants of its own

## Indications for use
The REMstar Auto CPAP System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea. For use in the home or hospital/institutional environment on adult patients.

Source page: https://510kreport.com/device/K031460
Methodology: https://510kreport.com/methodology