# K041974: MED2000 Nebulizer Compressor, Models P3, P4, P5 with Nebulizer

- Pathway: 510(k) (Special)
- Applicant: Med2000 S.R.L.
- Decided: Aug 24, 2004 after 33 days
- Product code: BTI (Compressor, Air, Portable)
- Device class: 2
- Regulation: 21 CFR 868.6250
- 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 Compressors, Models P3, P4 and P5, with Nebulizer, are AC-powered air compressors intended to provide a source of compressed air for medical purposes for use in home health care. These devices are provided with the Model Al/C (AndyFlow) pneumatic nebulizer and should only be used with this nebulizer to produce a fine aerosol mist of medication for respiratory therapy, for inhalation by a patient for treatment of respiratory disorders such as allergies, asthma, cystic fibrosis, COPD, etc. It can be used with adult or pediatric patients.

Source page: https://510kreport.com/device/K041974
Methodology: https://510kreport.com/methodology