# K244035: Portable mesh nebulizer (JM821)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Jermei Medical Device Technology Co., Ltd.
- Decided: Sep 19, 2025 after 263 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 K923024 (1992). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201397: Ultrasonic Mesh Nebulizer, Shenzhen Ivankaca Technology Co., Ltd. (2021) Summary page 5.

## Indications for use
The portable mesh nebulizer is intended to aerosolize medicine liquid for inhalation by the patient. The device is used with adult and pediatric (≥3 years old) both in hospital, home, and sub-acute settings. It is not intended for use with Pentamidine.

Source page: https://510kreport.com/device/K244035
Methodology: https://510kreport.com/methodology