Cleared Traditional

Accu-Chek FlexLink Plus infusion set (K143446) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 234
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K143446.
Medline Blood Collection Set
K170002 · Medline Industries, Inc. · Sep 2017
PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set
K153440 · C.R. Bard, Inc. · Aug 2016
Extension Set
K153293 · B.Braun Medical, Inc. · Apr 2016
IV Administration Sets with 200(micro)m Blood Filter
K143082 · B.Braun Medical, Inc. · Jul 2015
IV ADMINISTRATION SET WITH HAND PUMP
K140838 · B.Braun Medical, Inc. · Dec 2014
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS
K142036 · B.Braun Medical, Inc. · Aug 2014