510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Kung Shin Plastics Co. Ltd.

New Taipei City, TW

KUNG SHIN PLASTICS CO., LTD. appears in FDA device records in New Taipei City, TW. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
2
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Kung Shin Plastics Co. Ltd. in 2004.

Clearances by year, as a table
510(k) clearance decisions for Kung Shin Plastics Co. Ltd., by decision year
YearClearances
20041
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K032878KUNG SHIN, HMEF SK203CAHSubstantially Equivalent

Registered establishments

FDA registered establishments for Kung Shin Plastics Co. Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30041160323004116032KUNG SHIN PLASTICS CO., LTD.1F., No. 61, Jia 5th St., NEW TAIPEI CITY 239003 TW2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1269-2025CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)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.Class IIOpen, Classified
Z-1268-2025CircuitGuard 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.Class IIOpen, Classified

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain