Cleared Traditional

K171957 - MaxZero Extension Sets with Needless Connector (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K171957 · Carefusion 303, Inc. · General Hospital
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Jul 2017
Decision
20d
Days
Class 2
Risk

K171957 is an FDA 510(k) clearance for the MaxZero Extension Sets with Needless Connector. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Carefusion 303, Inc. (San Diego, US). The FDA issued a Cleared decision on July 19, 2017 after a review of 20 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Carefusion 303, Inc. devices

Submission Details

510(k) Number K171957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2017
Decision Date July 19, 2017
Days to Decision 20 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 128d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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

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