# K905540: Respironics Bipap Remote Control Unit

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Jan 30, 1991 after 50 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
No predicates in its family tree.
47 later devices descend from it; 3 cite it directly.
9 of 48 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
- K955324: Bipap S/T-D 30 System (1996), 44 descendants of its own
- K982454: Bipap Vision Ventilatory Support (1998), 42 descendants of its own
- K082660: V60 Ventilator, Model V8000 (2009), 14 descendants of its own
- K053168: Bipap Focus (2006), 11 descendants of its own
- K071560: Provent Nasal Dilator, Model BR2 (2008), 10 descendants of its own

Source page: https://510kreport.com/device/K905540
Methodology: https://510kreport.com/methodology