# K111246: Spirale Drug Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Armstrong Medical, Ltd.
- Decided: Aug 10, 2012 after 464 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) Trudell Aerovent collapsible Holding Chamber (Monaghan Medical): named in the summary without a submission number

## Indications for use
Spirale DDS is a collapsible volumising chamber for the delivery of aerosolized micro drug particles from an MDI (metered dose inhaler) canister into a respiratory breathing circuit during anaesthesia or intensive care ventilation in the spontaneously-breathing or ventilated patient.

Source page: https://510kreport.com/device/K111246
Methodology: https://510kreport.com/methodology