# K011714: Bipap Pro BI-Level System

- Pathway: 510(k) (Special)
- Applicant: Respironics, Inc.
- Decided: Jun 28, 2001 after 24 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000994 (2000). 1 ancestor in all.
103 later devices descend from it; 4 cite it directly.
24 of 105 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000994: Bipap Duet LX BI-Level System, Respironics, Inc. (2000) Summary page 1.

## Most influential descendants
- K020777: Bipap Synchrony Ventilatory Support System with BI-Flex (2002), 61 descendants of its own
- K070328: Bipap Synchrony with Avaps (2007), 59 descendants of its own
- K031656: Bipap Harmony Ventilatory Support System (2003), 52 descendants of its own
- K021861: Remstar Pro with C-Flex Cpap System (2002), 47 descendants of its own
- K052110: M-Series Pro Cpap Sytem (2005), 42 descendants of its own

## Recalls of this device
- Oct 15, 2007 · Not classified · Z-1076-2008: Foreign material: Glass fragments may present in the plastic bag material used to ship components.

## Indications for use
The Respironics BiPAP® Pro Bi-level System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea only.

Source page: https://510kreport.com/device/K011714
Methodology: https://510kreport.com/methodology