Cleared Traditional

K171957 - MaxZero Extension Sets with Needless Connector

K171957 is an FDA 510(k) clearance for MaxZero Extension Sets with Needless Co..., manufactured by Carefusion 303, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K171957 · Carefusion 303, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K171957

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 129d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FPA Set, Administration, Intravascular

All 871
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K171957.
Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s)
K171118 · Cair Lgl · Aug 2017
Carefusion NeutraClear Needle-free connector
K171132 · Cair Lgl · Jul 2017
TUBETECH IV Administration Set
K162951 · Douglas Medical Products, Inc. · Jul 2017
Solution Set with 1.2 Micron Air Eliminating Filter
K161808 · Baxter Healthcare Corporation · Jun 2017
Encore Neutral
K162826 · Rymed Technologies, LLC · Jun 2017
Closed Male Luer
K171101 · Yukon Medical · Jun 2017

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.