# K072670: Modification to: Eflow Electronic Inhaler/Nebulizer

- Pathway: 510(k) (Special)
- Applicant: Pari Innovative Manufacturers, Inc.
- Decided: Dec 13, 2007 after 83 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: 3 generations back to K970010 (1997). 5 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have 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 2.

## Most influential descendants
- K100380: Altera Nebulizer System, Model 678G1002 (2010), 4 descendants of its own
- K112859: Erapid Nebulizer System (2012), 3 descendants of its own
- 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 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 and pediatric patients.

Source page: https://510kreport.com/device/K072670
Methodology: https://510kreport.com/methodology