Cleared Traditional

K032878 - KUNG SHIN, HMEF SK203

K032878 is an FDA 510(k) clearance for KUNG SHIN, manufactured by Kung Shin Plastics Co., Ltd.. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 371-day FDA review.

K032878 · Kung Shin Plastics Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
371d
Days
Class 2
Risk

K032878 is an FDA 510(k) clearance for the KUNG SHIN, HMEF SK203. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Kung Shin Plastics Co., Ltd. (Hsin Chu City, TW). The FDA issued a Cleared decision on September 20, 2004 after a review of 371 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 868.5260 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Kung Shin Plastics Co., Ltd. devices

FDA 510(k) Submission Details - K032878

510(k) Number K032878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2003
Decision Date September 20, 2004
Days to Decision 371 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
242d slower than avg
Panel avg: 129d · This submission: 371d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAH Device Classification - Class 2, Special Controls

Product Code CAH Filter, Bacterial, Breathing-circuit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5260
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - CAH Filter, Bacterial, Breathing-circuit

All 126
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K032878.
HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD CLEAR BREATHING FILTER
K092409 · Intersurgical, Inc. · Mar 2010
RT019 INSPIRATORY/EXPIRATORY FILTER
K050927 · Fisher &Paykel Healthcare , Ltd. · Aug 2005
MIN-FILTER/S, UNI-FILTER JUNIOR, UNI-FILTER/S ANGLED AND UNI-FILTER
K043120 · Datex-Ohmeda, Inc. · Mar 2005
CLEAR-THERM MICRO HME, MODEL 1441
K032322 · Intersurgical, Inc. · May 2004
VENTLAB BACTERIAL FILTER, MODEL BF100
K030271 · Ventlab Corp. · Jul 2003
DATEX-OHMEDA MINI-FILTER/S AND UNI-FILTER JUNIOR
K030990 · Datex-Ohmeda · Jun 2003