# K000994: Bipap Duet LX BI-Level System

- Pathway: 510(k) (Special)
- Applicant: Respironics, Inc.
- Decided: Jun 22, 2000 after 86 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
No predicates in its family tree.
104 later devices descend from it; 1 cites 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K011714: Bipap Pro BI-Level System (2001), 103 descendants of its own
- 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

## Recalls of this device
- Oct 15, 2007 · Not classified · Z-1081-2008: Foreign material: Glass fragments may present in the plastic bag material used to ship components.

Source page: https://510kreport.com/device/K000994
Methodology: https://510kreport.com/methodology