Cleared Traditional

K193088 - MaxZero Extension Sets with Needle-Free Connector(s)

K193088 is an FDA 510(k) clearance for MaxZero Extension Sets with Needle-Free..., manufactured by Carefusion, Inc.. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K193088

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.

FPA Device Classification - Class 2, Special Controls

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 769
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