# K033833: Eflow Electronic Inhaler/Nebulizer

- Pathway: 510(k) (Traditional)
- Applicant: Pari Innovative Manufacturers, Inc.
- Decided: May 5, 2004 after 147 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 K970010 (1997). 4 ancestors in all.
10 later devices descend from it; 4 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992831: Aeroneb II, Model Apn 200, Aerogen, Inc. (2000). Our reading of the summary gave K992381, FDA’s number for CO2 Gas Warmer II, Model 6-800-00 (Northgate Technologies, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “AeroNeb H1j Portable Nebulizer”.
- K003022: Aeroneb Portable Nebulizer, Aerogen, Inc. (2000) Summary page 1.
- K963924: LC Star Reusable Nebulizer 22F50 and LC Star Disposable Nebulizer 22F70, Pari Holding Co. (1996) Summary page 1.

## Most influential descendants
- K072670: Modification to: Eflow Electronic Inhaler/Nebulizer (2007), 5 descendants of its own
- K100380: Altera Nebulizer System, Model 678G1002 (2010), 4 descendants of its own
- K112859: Erapid Nebulizer System (2012), 3 descendants of its own
- K072019: AKITA2 Apixneb (2007), 3 descendants of its own
- K223840: eRapid Nebulizer System (2023), 1 descendant of its own

## Indications for use
The eFlow is a handheld nebulizer that will be used with patients for whom doctors have prescribed medication for nebulization. The eFlow is intended for adult mid pediatric patients.

Source page: https://510kreport.com/device/K033833
Methodology: https://510kreport.com/methodology