Cleared Traditional

K123344 - K-SHIELD ADVANTAGE PORT ACCESS INFUSION...

K123344 is the FDA 510(k) clearance for K-SHIELD ADVANTAGE PORT ACCESS INFUSION... by Kawasumi Laboratories, Inc.. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K123344 · Kawasumi Laboratories, Inc. · General Hospital
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Mar 2013
Decision
127d
Days
Class 2
Risk

K123344 is an FDA 510(k) clearance for the K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS). Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Kawasumi Laboratories, Inc. (Kenosha, US). The FDA issued a Cleared decision on March 7, 2013 after a review of 127 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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. Standard predicate reliance. 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 Kawasumi Laboratories, Inc. devices

Submission Details

510(k) Number K123344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2012
Decision Date March 07, 2013
Days to Decision 127 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 129d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 446
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