Cleared Traditional

K140831 - MAXZERO EXTENSION SET WITH NEEDLESS CONNECTOR

K140831 is an FDA 510(k) clearance for MAXZERO EXTENSION SET WITH NEEDLESS CON..., manufactured by Care Fusion. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K140831 · Care Fusion · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
13d
Days
Class 2
Risk

K140831 is an FDA 510(k) clearance for the MAXZERO EXTENSION SET WITH NEEDLESS CONNECTOR. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Care Fusion (San Diego, US). The FDA issued a Cleared decision on April 15, 2014 after a review of 13 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 Care Fusion devices

FDA 510(k) Submission Details - K140831

510(k) Number K140831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2014
Decision Date April 15, 2014
Days to Decision 13 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
116d faster than avg
Panel avg: 129d · This submission: 13d
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 768
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K140831.
NEXUS NIS-6P LUER ACTIVATED DEVICE
K133351 · Nexus Medical, LLC · May 2014
INFUSET FLOW CONTROL EXTENSION SET
K140133 · Emed Technologies Corporation · May 2014
CARESITE LUER ACCESS DEVICE
K140311 · B.Braun Medical, Inc. · May 2014
SUB-Q SUBCUTANEOUS TISSUE INFUSION SET
K140131 · Emed Technologies Corporation · Apr 2014
CAIR DRIVE, NEUTRACLEAR
K133073 · Cair Lgl · Mar 2014
SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD)
K133894 · Terumo Europe N.V. · Mar 2014

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.