# K031908: MED2000 Spa Nebulizer Compressors, Models P1 and P2, with Nebulizer, and MED2000 Spa Nebulizer, Model A1/C (Andyflow)

- Pathway: 510(k) (Traditional)
- Applicant: Med2000 S.R.L.
- Decided: Jan 14, 2004 after 208 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: 3 generations back to K870027 (1987). 6 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013027: Mister Neb Nebulizer Compressor, with Nebulizer, Model HS123, Respironics Healthscan, Inc. (2001) Summary page 1.
- K961476: Salterlabs 8960 Series Nebulizer (8960/8961/8966/8984), Salter Labs (1996) Summary page 1.
- K014056: Salter Labs Modified Nebutech Nebulizer, Salter Labs (2002) Summary page 1.
- K021742: Galemed Neb-Easy Nebulizer, Galemed Corp. (2002) Summary page 1.

## Most influential descendants
- K051365: Compressor Nebulizer System, Model KN-9321 (2005), 1 descendant of its own
- K083256: Ultrasonic Nebulizer System, Model KN-9210 (2009), 0 descendants of its own
- K041974: MED2000 Nebulizer Compressor, Models P3, P4, P5 with Nebulizer (2004), 0 descendants of its own
- K041327: MED2000 Spa Nebulizer Andyflow, Model A1/C with Accessories (2004), 0 descendants of its own

## Indications for use
The Med2000 SpA Nebulizer Compressors, Models P1 and P2, are AC-powered air compressors, with adapter, 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. 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.

Source page: https://510kreport.com/device/K031908
Methodology: https://510kreport.com/methodology