# K223840: eRapid Nebulizer System

- Pathway: 510(k) (Traditional)
- Applicant: Pari Respiratory Equipment, Inc.
- Decided: Aug 11, 2023 after 232 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: 7 generations back to K933535 (1994). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 20 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112859: Erapid Nebulizer System, Pari Respiratory Equipment, Inc. (2012) Summary page 4.

## Most influential descendants
- K251572: eRapid with eTrack System (2025), 0 descendants of its own

## Indications for use
The eRapid NCP Nebulizer System is to be used with patients for whom doctors have prescribed medicine for nebulization. It is intended for adult and pediatric patients age 4 and older who can coordinate breathing through a mouthpiece, and may be used in hospitals, hospital-type facilities, nursing homes, sub-acute institutions and home environments.

Source page: https://510kreport.com/device/K223840
Methodology: https://510kreport.com/methodology