# K870051: Spag-2 Aerosol Generator W/Use of Virazole

- Pathway: 510(k) (Traditional)
- Applicant: Viratek, Inc.
- Decided: Oct 6, 1987 after 273 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- Recalls of this device: 2 (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
- Sep 21, 2015 · Class II · Z-0674-2016: The Serial I.D. Label and some information in the Operation Manual for the SPAG 2 6000 series is incorrect or out of date, including references to accessories that are no longer available.
- Sep 14, 2015 · Class II · Z-0371-2016: SPAG-2 6000 Lot J3522070 was released to commerce without being tested for particle size per quality control procedure SPAG-2515.

Source page: https://510kreport.com/device/K870051
Methodology: https://510kreport.com/methodology