Cleared Traditional

K193088 - MaxZero Extension Sets with Needle-Free...

K193088 is the FDA 510(k) clearance for MaxZero Extension Sets with Needle-Free... by Carefusion, Inc.. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 352-day FDA review.

K193088 · Carefusion, Inc. · General Hospital
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Oct 2020
Decision
352d
Days
Class 2
Risk

K193088 is an FDA 510(k) clearance for the MaxZero Extension Sets with Needle-Free Connector(s). Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Carefusion, Inc. (Brea, US). The FDA issued a Cleared decision on October 23, 2020 after a review of 352 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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 Carefusion, Inc. devices

Submission Details

510(k) Number K193088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2019
Decision Date October 23, 2020
Days to Decision 352 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
223d slower than avg
Panel avg: 129d · This submission: 352d
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 445
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