Cleared Traditional

K171118 - Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s)

K171118 is an FDA 510(k) clearance for Carefusion NeutraClear multi-fuse Exten..., manufactured by Cair Lgl. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K171118 · Cair Lgl · General Hospital
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Aug 2017
Decision
123d
Days
Class 2
Risk

K171118 is an FDA 510(k) clearance for the Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s). 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 August 15, 2017 after a review of 123 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. 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. Standard predicate reliance. 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 Cair Lgl devices

FDA 510(k) Submission Details - K171118

510(k) Number K171118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2017
Decision Date August 15, 2017
Days to Decision 123 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
6d faster than avg
Panel avg: 129d · This submission: 123d
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 871
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K171118.
IV Fat Emulsion Administration Sets
K172544 · Baxter Healthcare Corporation · Sep 2017
Medline Blood Collection Set
K170002 · Medline Industries, Inc. · Sep 2017
Carefusion NeutraClear Needle-free connector (EL-NC1000)
K171117 · Cair Lgl · Sep 2017
Carefusion NeutraClear Needle-free connector
K171132 · Cair Lgl · Jul 2017
TUBETECH IV Administration Set
K162951 · Douglas Medical Products, Inc. · Jul 2017
MaxZero Extension Sets with Needless Connector
K171957 · Carefusion 303, Inc. · Jul 2017