# K041327: MED2000 Spa Nebulizer Andyflow, Model A1/C with Accessories

- Pathway: 510(k) (Special)
- Applicant: Med2000 S.R.L.
- Decided: Jul 20, 2004 after 63 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
Longest line of descent: 4 generations back to K870027 (1987). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031908: MED2000 Spa Nebulizer Compressors, Models P1 and P2, with Nebulizer, and MED2000 Spa Nebulizer, Model A1/C (Andyflow), Med2000 S.R.L. (2004) Summary page 1.

## Indications for use
The Med2000 SpA Nebulizer, Model Al/C (AndyFlow) with Accessories, is a pneumatic nebulizer which, when driven by a compatible air compressor, nebulizes specific inhalable drugs for inhalation by a patient. It can be used with adult or pediatric patients. The Med2000 SpA Nebulizer, Model Al/C (AndyFlow) with Accessories, may be used with compatible compressors or an air gas source providing between 4 and 8 Ipm.

Source page: https://510kreport.com/device/K041327
Methodology: https://510kreport.com/methodology