# K063830: Remstar Aflex Cpap System

- Pathway: 510(k) (Special)
- Applicant: Respironics Inc., Sleep & Home Respiratory Group
- Decided: Mar 9, 2007 after 73 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: 7 generations back to K953930 (1996). 28 ancestors in all.
35 later devices descend from it; 3 cite it directly.
12 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052110: M-Series Pro Cpap Sytem, Respironics, Inc. (2005) Summary page 1.
- K050759: Bipap Auto, Respironics, Inc. (2005) Summary page 1.
- K041209: Resmed S8 Pioneer Cpap System, Resmed, Ltd. (2004) Summary page 1.

## Cited in the summary but kept off the family tree
- K040101: Modification to Diadexus Plac Test, Diadexus, Inc. (2004). Our OCR of the scanned summary read K040101, FDA’s number for Modification to Diadexus Plac Test (Diadexus, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Respironics REMstar Auto C-Flex CPAP System”. Kept off the family tree. Summary page 1.

## Most influential descendants
- 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
- K113068: Remstar Auto a-Flex HT (2011), 9 descendants of its own
- K113053: Bipap a 30 Ventilatory Support System (2012), 8 descendants of its own

## Indications for use
The Respironics REMstar Auto M-Series with AFLEX Series 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/K063830
Methodology: https://510kreport.com/methodology