# K032878: Kung Shin, Hmef SK203

- Pathway: 510(k) (Traditional)
- Applicant: Kung Shin Plastics Co., Ltd.
- Decided: Sep 20, 2004 after 371 days
- Product code: CAH (Filter, Bacterial, Breathing-Circuit)
- Device class: 2
- Regulation: 21 CFR 868.5260
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Jan 9, 2025 · Class II · Z-1269-2025: The machine side connector of the filter HME may be occluded by plastic which prevents proper airflow. The issue may lead to ventilation bag malfunction in which the user is unable to inflate/deflate 
- Jan 9, 2025 · Class II · Z-1268-2025: The machine side connector of the filter HME may be occluded by plastic which prevents proper airflow. The issue may lead to ventilation bag malfunction in which the user is unable to inflate/deflate 

## Indications for use
The HMEF SK203 is a disposable single-use device indicated for adult patients who require humidification during the delivery of ventilator gases and provide filtration for reducing possible cross contamination between patient and equipment. The HMEF SK203 is for use in hospital, ICU, anesthesia, respiratory therapy, during transport and with resuscitators. The device can be used on adult patients. The device is indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K032878
Methodology: https://510kreport.com/methodology