# K971260: Sullivan Humidaire Heated Humidifier

- Pathway: 510(k) (Traditional)
- Applicant: Resmed Corp
- Decided: Sep 4, 1997 after 153 days
- Product code: BTT (Humidifier, Respiratory Gas, (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
138 later devices descend from it; 2 cite it directly.
13 of 139 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K013909: S7 Elite CP AP System (2002), 128 descendants of its own
- K013843: Autoset Spirit Cpap System (2002), 125 descendants of its own
- K024191: S7 Elite and Autoset Spirit Cpap Systems with Reslink (2003), 110 descendants of its own
- K030843: Vpap Iii (2003), 106 descendants of its own
- K033841: Resmed S8 Prime Cpap System (2004), 100 descendants of its own

## Indications for use
The HumidAire™ Heated Humidifier is indicated for the humidification and warming of the air from nasal Continuous Positive Airway Pressure (CPAP) and bi-level systems, but not autoset systems. The HumidAire is for prescription use only.

Source page: https://510kreport.com/device/K971260
Methodology: https://510kreport.com/methodology