Cleared Special

PIVO (K190604) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K190604 · Velano Vascular · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2019
Decision
66d
Days
Class 2
Risk

K190604 is an FDA 510(k) clearance for the PIVO. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Velano Vascular (San Francisco, US). The FDA issued a Cleared decision on May 13, 2019 after a review of 66 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 862.1675 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Velano Vascular devices

Submission Details

510(k) Number K190604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2019
Decision Date May 13, 2019
Days to Decision 66 days
Submission Type Special
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
63d faster than avg
Panel avg: 129d · This submission: 66d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1675
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 - JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

All 100
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K190604.
Blood Transfer Accessory (BTA)
K181743 · Nsp Tech Pte, Ltd. · Jul 2019
Blood Collection Accessory (BUCA)
K181754 · Nsp Tech Pte, Ltd. · Jul 2019
Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)
K190485 · Kawasumi Laboratories, Inc. · Jul 2019
MiniCollect K2E K2EDTA Tubes
K182078 · Greiner Bio-One Na, Inc. · Jan 2019
Kurin PIV Blood Collection Set with High Pressure
K181895 · Kurin, Inc. · Jan 2019
Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder
K172763 · Zhejiang Kindly Medical Devices Co., Ltd. · Jun 2018