# K970010: FPT Nebulizer

- Pathway: 510(k) (Traditional)
- Applicant: Fluid Propulsion Technologies, Inc.
- Decided: Apr 1, 1997 after 89 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
No predicates in its family tree.
15 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K992831: Aeroneb II, Model Apn 200 (2000), 11 descendants of its own
- K033833: Eflow Electronic Inhaler/Nebulizer (2004), 10 descendants of its own
- 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

Source page: https://510kreport.com/device/K970010
Methodology: https://510kreport.com/methodology