# K970516: Sullivan Autoset Home Nasal Cpap System

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: May 9, 1997 after 87 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.
21 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K030985: Breas PV 10I Cpap System, Model PV 10I (2003), 20 descendants of its own
- K063476: Breas Isleep 20I (2007), 12 descendants of its own
- K071560: Provent Nasal Dilator, Model BR2 (2008), 10 descendants of its own
- K042945: Aura Cpap System (2005), 6 descendants of its own
- K111549: Attune Sleep Apnea System (2012), 5 descendants of its own

Source page: https://510kreport.com/device/K970516
Methodology: https://510kreport.com/methodology