Cleared Traditional

K143446 - Accu-Chek FlexLink Plus infusion set

K143446 is an FDA 510(k) clearance for Accu-Chek FlexLink Plus infusion set, manufactured by Roche Diagnostics GmbH. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K143446 · Roche Diagnostics GmbH · General Hospital
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Optimized for regulatory review, auditing and printing
Aug 2015
Decision
254d
Days
Class 2
Risk

K143446 is an FDA 510(k) clearance for the Accu-Chek FlexLink Plus infusion set. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Roche Diagnostics GmbH (Mannheim, DE). The FDA issued a Cleared decision on August 13, 2015 after a review of 254 days - an extended review 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: 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 Roche Diagnostics GmbH devices

FDA 510(k) Submission Details - K143446

510(k) Number K143446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2014
Decision Date August 13, 2015
Days to Decision 254 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
125d slower than avg
Panel avg: 129d · This submission: 254d
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 570
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K143446.
Solution Administration Sets with 0.2 Micron Filter
K153158 · Baxter Healthcare Corporation · Dec 2015
BD FlowSmart Set, MiniMed Pro-Set
K153257 · Becton, Dickinson and Company · Dec 2015
Q2 Intravenous Adminstration Sets and Extension Sets
K151079 · Quest Medical, Inc. · Sep 2015
IV Administration Sets with 200(micro)m Blood Filter
K143082 · B.Braun Medical, Inc. · Jul 2015
Nitroglycerin Sets with DUO-VENT Spike
K150860 · Baxter Healthcare Corporation · Apr 2015
Hospira Blood Set
K143087 · Hospira, Inc. · Mar 2015