Cleared Traditional

Velano Vascular Q2 Extension Set (K182897) - FDA 510(k) Clearance

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

K182897 · Velano Vascular · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2019
Decision
161d
Days
Class 2
Risk

K182897 is an FDA 510(k) clearance for the Velano Vascular Q2 Extension Set. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Velano Vascular (San Francisco, US). The FDA issued a Cleared decision on March 26, 2019 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 Velano Vascular devices

Submission Details

510(k) Number K182897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2018
Decision Date March 26, 2019
Days to Decision 161 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
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 237
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K182897.
Clearlink System Solution Set
K180739 · Baxter Healthcare Corporation · May 2019
K-Shield Advantage Port Access Infusion Set (PAIS)
K190233 · Kawasumi Laboratories, Inc. · May 2019
HIgH-Flo Super26 Subcutaneous Needle Sets
K180843 · Repro-Med Systems, Inc. Dba Rms Medical Products · Apr 2019
Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use
K181870 · Wuhan W.E.O Science & Technology Development Co., Ltd. · Feb 2019
Tamper Evident Cap with Male Luer Lock
K182545 · International Medical Industries, Inc. · Jan 2019
BD FlowSmart Set/MiniMed Pro-Set
K181718 · Becton, Dickinson and Company · Oct 2018