Cleared Traditional

Sterile Single-use Infusion Set (K163160) - FDA 510(k) Clearance

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

K163160 · Jiangxi Hongda Medical Equipment Group , Ltd. · General Hospital
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Apr 2017
Decision
161d
Days
Class 2
Risk

K163160 is an FDA 510(k) clearance for the Sterile Single-use Infusion Set. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Jiangxi Hongda Medical Equipment Group , Ltd. (Nanchang, CN). The FDA issued a Cleared decision on April 20, 2017 after a review of 161 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 Jiangxi Hongda Medical Equipment Group , Ltd. devices

Submission Details

510(k) Number K163160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2016
Decision Date April 20, 2017
Days to Decision 161 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
32d slower than avg
Panel avg: 129d · This submission: 161d
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 238
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K163160.
MiniMed Mio Advance infusion set
K173879 · Unomedical A/S · Mar 2018
IV Administration Sets
K170595 · B.Braun Medical, Inc. · Nov 2017
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
BD FlowSmart Set, MiniMed Pro-Set
K160651 · Becton, Dickinson and Company · Apr 2016
Extension Set
K153293 · B.Braun Medical, Inc. · Apr 2016