# K962872: Respiflo

- Pathway: 510(k) (Traditional)
- Applicant: Tyco Healthcare Deutschaland GmbH
- Decided: Feb 25, 1997 after 217 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- Recalls of this device: none
- 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. The FDA summary names its predicate without a number.
- (no number) Hudson RCI AQUAPAK: named in the summary without a submission number

## Indications for use
For Inhalation and Humidification by way of Sterile Water in a closed system during Inhalation Therapy.

Source page: https://510kreport.com/device/K962872
Methodology: https://510kreport.com/methodology