KUNG SHIN, HMEF SK203— 510(k) K032878
Substantially EquivalentKung Shin Plastics Co., Ltd.
FDA 510(k) clearance K032878 for KUNG SHIN, HMEF SK203, Substantially Equivalent on 2004-09-20. Applicant: Kung Shin Plastics Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Kung Shin Plastics Co., Ltd.
- Product code
- Code CAH
- Device class
- Class 2
- Regulation
- 21 CFR 868.5260
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hsin Chu City, TW
Recent devices under product code CAH
view allAdverse events under product code CAH
product code CAH- Death
- 7
- Total
- 7
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K032878
K-number listed on FDA's recall record- Z-1268-2025 — CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126)
- Z-1269-2025 — CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K032878.
Data sourced from openFDA. This site is unofficial and independent of the FDA.