# K250964: Protable Phlegm Suction Unit (JMA D01)

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Jumao X-Care Medical Equipment Co., Ltd.
- Decided: May 11, 2026 after 406 days
- Product code: JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 878.4780
- 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 K935218 (1994). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182950: Acare Suction Unit, Acare Technology Co., Ltd. (2019) Summary page 5.

## Indications for use
The device is to be used to remove fluids from the airway or respiratory system. The device creates a negative pressure (vacuum) that draws fluids through disposable tubing that is connected to a collection canister. The fluids are trapped in the collection canister for proper disposal. It is for use on the order of a physician only.

Source page: https://510kreport.com/device/K250964
Methodology: https://510kreport.com/methodology