Cleared Traditional

K171117 - Carefusion NeutraClear Needle-free connector (EL-NC1000)

K171117 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 Traditional 510(k) pathway after a 140-day FDA review.

K171117 · Cair Lgl · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
140d
Days
Class 2
Risk

K171117 is an FDA 510(k) clearance for the Carefusion NeutraClear Needle-free connector (EL-NC1000). 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 September 1, 2017 after a review of 140 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 - K171117

510(k) Number K171117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2017
Decision Date September 01, 2017
Days to Decision 140 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
11d slower than avg
Panel avg: 129d · This submission: 140d
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 K171117.
Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion Set
K162812 · Unomedical A/S · Nov 2017
IV Fat Emulsion Administration Sets
K172544 · Baxter Healthcare Corporation · Sep 2017
Medline Blood Collection Set
K170002 · Medline Industries, Inc. · Sep 2017
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