# K014056: Salter Labs Modified Nebutech Nebulizer

- Pathway: 510(k) (Special)
- Applicant: Salter Labs
- Decided: Feb 1, 2002 after 53 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: 2 generations back to K870027 (1987). 2 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961476: Salterlabs 8960 Series Nebulizer (8960/8961/8966/8984), Salter Labs (1996) Summary page 1.

## Most influential descendants
- K031908: MED2000 Spa Nebulizer Compressors, Models P1 and P2, with Nebulizer, and MED2000 Spa Nebulizer, Model A1/C (Andyflow) (2004), 4 descendants of its own
- 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
This product is a nebulizer used to generate aerosols that are delivered directly to the patient for breathing. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer. This product is a single patient use, non-sterile prescription device and is designed to be used in either a hospital or homecare environment.

Source page: https://510kreport.com/device/K014056
Methodology: https://510kreport.com/methodology