Kung Shin Plastics Co. Ltd.
FDA Regulatory Profile
Kung Shin Plastics Co. Ltd. appears in FDA public data with 2 recalls, 1 510(k) clearance, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1269-2025, Class II) was initiated on January 9, 2025. Its most recent 510(k) clearance was granted on September 20, 2004.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 1
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
| Z-1269-2025 | Class II | CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056) | January 9, 2025 |
| Z-1268-2025 | Class II | CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Por | January 9, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
| K032878 | KUNG SHIN, HMEF SK203 | September 20, 2004 |