# K955805: Dual Spray Minispacer

- Pathway: 510(k) (Traditional)
- Applicant: Thayer Medical Corp.
- Decided: Mar 21, 1996 after 90 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Jun 6, 2012 · Class II · Z-1927-2012: Internal data identified a molding defect in the 15 mm O.D. / I.D. MiniSpacer meter dose inhaler (MDI) adapter that results in an incomplete fill of the aerosol dispensing pathway.

Source page: https://510kreport.com/device/K955805
Methodology: https://510kreport.com/methodology