# K100380: Altera Nebulizer System, Model 678G1002

- Pathway: 510(k) (Traditional)
- Applicant: Pari Respiratory Equipment, Inc.
- Decided: Feb 22, 2010 after 6 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: 5 generations back to K933535 (1994). 15 ancestors in all.
4 later devices descend 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)
- 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 2.
- K042991: I-Neb Aad System, Profile Therapeutics Plc (2005) Summary page 2.

## Most influential descendants
- 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 Altera™ Nebulizer System is intended specifically for the aerosolization of Cayston™ (aztreonam for inhalation solution) using vibrating membrane technology. The device is intended for adult and pediatric patients who have been prescribed Cayston, and may be used in hospitals, hospital-type facilities, nursing homes, sub-acute institutions and home environments.

Source page: https://510kreport.com/device/K100380
Methodology: https://510kreport.com/methodology