# K032834: Bipap Pro 2 BI-Level System

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Mar 4, 2004 after 175 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). 13 ancestors in all.
40 later devices descend from it; 1 cites it directly.
12 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011714: Bipap Pro BI-Level System, Respironics, Inc. (2001) Summary page 1.
- K012554: Remstar Auto Cpap System, Respironics, Inc. (2002) Summary page 1.
- K031460: Modification to Remstar Auto Cpap System, Respironics, Inc. (2003) Summary page 1.
- K031656: Bipap Harmony Ventilatory Support System, Respironics, Inc. (2003) Summary page 1.
- K961783: Sullivan Vpap II ST Nasal Vpap System, Resmed, Ltd. (1996) Summary page 1.

## Most influential descendants
- 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
- K091319: Remstar Auto a-Flex (2009), 22 descendants of its own
- K092818: Bipap Avaps Ventilatory Support System (2010), 11 descendants of its own

## Indications for use
The Respironics BiPAP Pro 2 Bi-level System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea only. For use in the home or hospital/institutional environment on adult patients.

Source page: https://510kreport.com/device/K032834
Methodology: https://510kreport.com/methodology