# K905404: Medtronic Sullivan Nasal Cpap System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: May 13, 1991 after 161 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.
7 later devices descend from it; 1 cites it directly.
0 of 8 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
- K160836: Menai System (2016), 6 descendants of its own
- K200565: Galapogos (2021), 3 descendants of its own
- K241216: myAir (2024), 2 descendants of its own
- K250624: myAir (2025), 1 descendant of its own
- K252338: MySleepDash (2026), 0 descendants of its own

Source page: https://510kreport.com/device/K905404
Methodology: https://510kreport.com/methodology