# K061034: Bipap Plus M-Series BI-Level System

- Pathway: 510(k) (Special)
- Applicant: Respironics, Inc.
- Decided: Jun 23, 2006 after 70 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: 6 generations back to K953930 (1996). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 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 2.
- K043607: Bipap Pro 2 BI-Level System with BI-Flex, Respironics, Inc. (2005) Summary page 2.

## Indications for use
The Respironics BiPAP Plus M Series Bi-level System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg. For use in the home or hospital/institutional environment.

Source page: https://510kreport.com/device/K061034
Methodology: https://510kreport.com/methodology