# K201397: Ultrasonic Mesh Nebulizer

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Ivankaca Technology Co., Ltd.
- Decided: Jun 14, 2021 after 382 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: 4 generations back to K923024 (1992). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171549: Intelligent Mesh Nebulizer, Qingdao Future Medical Technology Co., Ltd. (2018) Summary page 5.

## Most influential descendants
- K244035: Portable mesh nebulizer (JM821) (2025), 0 descendants of its own

## Indications for use
The Ultrasonic Mesh Nebulizer designed to aerosolized liquid medications for inhalation by patient, the device may be used with pediatric (>4 years of age), defined by the prescribed medication, 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/K201397
Methodology: https://510kreport.com/methodology