# K112859: Erapid Nebulizer System

- Pathway: 510(k) (Traditional)
- Applicant: Pari Respiratory Equipment, Inc.
- Decided: May 30, 2012 after 243 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: 6 generations back to K933535 (1994). 17 ancestors in all.
3 later devices descend from it; 2 cite it directly.
1 of 21 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033833: Eflow Electronic Inhaler/Nebulizer, Pari Innovative Manufacturers, Inc. (2004) Summary page 1.
- K072670: Modification to: Eflow Electronic Inhaler/Nebulizer, Pari Innovative Manufacturers, Inc. (2007) Summary page 1.
- K963924: LC Star Reusable Nebulizer 22F50 and LC Star Disposable Nebulizer 22F70, Pari Holding Co. (1996) Summary page 1.
- K100380: Altera Nebulizer System, Model 678G1002, Pari Respiratory Equipment, Inc. (2010) Summary page 1.
- K930525: Micro Mist (TM) Nebulizer, Hudson Respiratory Care, Inc. (1993) Summary page 1.

## Most influential descendants
- K223840: eRapid Nebulizer System (2023), 1 descendant of its own
- K251572: eRapid with eTrack System (2025), 0 descendants of its own
- K162785: Velox Nebulizer System (2017), 0 descendants of its own

## Indications for use
The eRapid Tm Nebulizer System is a handheld nebulizer that will be used with patients for whom doctors have prescribed medication for nebulization. It is intended for adult and pediatric patients, and may be used in hospitals, hospital-type facilities, nursing homes, sub-acute institutions and home environments.

Source page: https://510kreport.com/device/K112859
Methodology: https://510kreport.com/methodology