# K994352: Side Draft Neb-U-Mist Nebulizer, Model 41896

- Pathway: 510(k) (Traditional)
- Applicant: Hudson Respiratory Care, Inc.
- Decided: Mar 22, 2000 after 90 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: 1 generation back to K930525 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930525: Micro Mist (TM) Nebulizer, Hudson Respiratory Care, Inc. (1993) Summary page 1.

## Indications for use
The Side Draft Neb-U-Mist Nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. This device is for single patient use and is not intended for reprocessing.

Source page: https://510kreport.com/device/K994352
Methodology: https://510kreport.com/methodology