Data / Medical devices / Taiwan / Kung Shin Plastics Co., Ltd.
Kung Shin Plastics Co., Ltd.: FDA-registered device maker in New Taipei City, Taiwan, 1 510(k) clearance
Kung Shin Plastics Co., Ltd. is registered with the FDA (registration 3004116032) in New Taipei City, Taiwan. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 20, 2004. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004116032
- Address
- 1F., No. 61, Jia 5th St. Yingge Dist., New Taipei City, Taiwan, 239003
- Owner or operator
- Kung Shin Plastics Co., Ltd. (9053835)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- November 8, 2002
- Registered through
- 2026
- Brand names listed
- KUNG SHIH, KUNG SHIN, SAYKIA VARIOUS MODEL O
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Catheter | KGZ | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Condenser, Heat And Moisture (Artificial Nose) | BYD | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Filter, Bacterial, Breathing-Circuit | CAH | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Humidifier, Non-Direct Patient Interface (Home-Use) | KFZ | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 20, 2004 | K032878 | KUNG SHIN, HMEF SK203 | CAH | Substantially Equivalent | Kung Shin Plastics Co., Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 9, 2025 | 96224 | Class II | Ongoing | CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126) | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Accessories, Catheter
- All makers of Circuit, Breathing (W Connector, Adaptor, Y Piece)
- All makers of Filter, Bacterial, Breathing-Circuit
- All makers of Humidifier, Non-Direct Patient Interface (Home-Use)
- All makers of Condenser, Heat And Moisture (Artificial Nose)
Updated March 4, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.