# K171549: Intelligent Mesh Nebulizer

- Pathway: 510(k) (Traditional)
- Applicant: Qingdao Future Medical Technology Co., Ltd.
- Decided: Aug 31, 2018 after 462 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 K923024 (1992). 3 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062263: Omron Micro-Air Vibrating Mesh Nebulizer, Model NE-U22, Omron Healthcare, Inc. (2007) Summary page 7.
- K132247: Ultrasonic Mesh Nebulizer, Foshan Gaunying Electronics Co., Ltd. (2014) Summary page 7.

## Most influential descendants
- K230379: Portable (Ultrasonic) Nebulizer (2023), 1 descendant of its own
- K201397: Ultrasonic Mesh Nebulizer (2021), 1 descendant of its own
- K254171: Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) (2026), 0 descendants of its own
- K251659: Mesh Nebulizer (H6) (2025), 0 descendants of its own
- K244035: Portable mesh nebulizer (JM821) (2025), 0 descendants of its own

## Indications for use
The Intelligent Mesh Nebulizer designed to aerosolized liquid medications for inhalation by patient, the device may be used with pediatric (>4 years of age) and adult patients in the home, hospital and sub-acute care settings. It is not intended for use with Pentamidine.

Source page: https://510kreport.com/device/K171549
Methodology: https://510kreport.com/methodology