# K964363: Bipap Duet System

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Jan 30, 1997 after 90 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: 1 generation back to K883825 (1988). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K883825: Modified Sanders BI-Papeasy, Respironics, Inc. (1988) Summary page 1.
- K905540: Respironics Bipap Remote Control Unit, Respironics, Inc. (1991) Summary page 1.

## Indications for use
The BiPAP Duet System delivers CPAP and bi-level positive airway pressure therapies for the treatment of adult OSA. The BiPAP Duet System is intended for use in the home and by a qualified clinician (any individual trained to perform sleep study diagnoses) in clinical (hospital or sleep laboratory) settings where adult patients suffering from OSA are diagnosed and treated. When used in clinical settings, the BiPAP Duet System can be used with or without the Respironics Maestro Clinical Remote Control. The BiPAP Duet System is used in conjunction with masks, headgear, and various combinations of patient circuit accessories.

Source page: https://510kreport.com/device/K964363
Methodology: https://510kreport.com/methodology