Kung Shin Plastics Co., Ltd.
TaiwanFDA 510(k) applicant, unverified FDA FEI 3004116032
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 22 ongoing
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
What Kung Shin Plastics Co., Ltd. makes
Kung Shin Plastics Co., Ltd. manufactures the KUNG SHIN HMEF SK203, a specific medical device designed for use in respiratory care, likely as a heat and moisture exchanger filter.
The company’s portfolio is regulated under FDA’s Class II designation and requires 510(k) clearance. The device is listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Kung Shin, Hmef SK203 Ref K032878
510(k) 510(k)
Company details
- FDA FEI number
- 3004116032
- Address
- 1F., No. 61, Jia 5th St., NEW TAIPEI CITY
FDA recalls
FDA recall records list 2 recalls initiated by Kung Shin Plastics Co., Ltd., initiated on 2025-01-09. By recorded status: 2 ongoing. The reasons filed fall into these groups: labeling or instructions for use. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 2
- 2026 0
2025
- 9 Jan 2025 Z-1268-2025 Class II Ongoing 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 properly during manual ventilation. Potential risks to health include oxygen deprivation, leading to respiratory distress and medical complications.
- 9 Jan 2025 Z-1269-2025 Class II Ongoing 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 properly during manual ventilation. Potential risks to health include oxygen deprivation, leading to respiratory distress and medical complications.
Frequently asked questions
How many devices does Kung Shin Plastics Co., Ltd. have in the registry?
The registry currently lists 1 device for Kung Shin Plastics Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Kung Shin Plastics Co., Ltd.'s devices?
Among its 1 most recently registered device, Kung Shin Plastics Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Kung Shin Plastics Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Kung Shin Plastics Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Kung Shin Plastics Co., Ltd.?
FDA recall records list 2 recalls initiated by Kung Shin Plastics Co., Ltd., the most recent initiated on 2025-01-09. 2 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Kung Shin Plastics Co., Ltd. in the registry?
The most recently registered devices listed for Kung Shin Plastics Co., Ltd. include KUNG SHIN, HMEF SK203.