# K780456: Nebulizer Heater

- Pathway: 510(k) (Traditional)
- Applicant: Travenol Laboratories, S.A.
- Decided: Apr 12, 1978 after 22 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Jul 13, 2011 · Not classified · Z-3016-2011: The recall was initiated because CareFusion's Investigation has confirmed the Nebulizer Heater can, over time, develop a failure mode that results in an internal electrical short. The short can result

Source page: https://510kreport.com/device/K780456
Methodology: https://510kreport.com/methodology