Cleared Special

K171132 - Carefusion NeutraClear Needle-free connector

K171132 is an FDA 510(k) clearance for Carefusion NeutraClear Needle-free conn..., manufactured by Cair Lgl. The device is a Class 2 General Hospital device with product code FPA cleared through the Special 510(k) pathway after a 105-day FDA review.

K171132 · Cair Lgl · General Hospital
Download Printable Device Report (PDF)
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Jul 2017
Decision
105d
Days
Class 2
Risk

K171132 is an FDA 510(k) clearance for the Carefusion NeutraClear Needle-free connector. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Cair Lgl (Lissieu, FR). The FDA issued a Cleared decision on July 31, 2017 after a review of 105 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cair Lgl devices

FDA 510(k) Submission Details - K171132

510(k) Number K171132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2017
Decision Date July 31, 2017
Days to Decision 105 days
Submission Type Special
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
24d faster than avg
Panel avg: 129d · This submission: 105d
Pathway characteristics
Modification to existing cleared device.

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

Wiesen Law Offices
IRVING WIESEN

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 K171132.
Medline Blood Collection Set
K170002 · Medline Industries, Inc. · Sep 2017
Carefusion NeutraClear Needle-free connector (EL-NC1000)
K171117 · Cair Lgl · Sep 2017
Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s)
K171118 · Cair Lgl · Aug 2017
TUBETECH IV Administration Set
K162951 · Douglas Medical Products, Inc. · Jul 2017
MaxZero Extension Sets with Needless Connector
K171957 · Carefusion 303, Inc. · Jul 2017
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K161808 · Baxter Healthcare Corporation · Jun 2017