Cleared Traditional

K230865 - PIVO Pro Needle-free Blood Collection D...

K230865 is the FDA 510(k) clearance for PIVO Pro Needle-free Blood Collection D... by Becton Dickinson Infusion Therapy Systems, Inc.. It is a Class 2 General Hospital device (product code JKA) cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K230865 · Becton Dickinson Infusion Therapy Systems, Inc. · General Hospital
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Sep 2023
Decision
183d
Days
Class 2
Risk

K230865 is an FDA 510(k) clearance for the PIVO™ Pro Needle-free Blood Collection Device. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Becton Dickinson Infusion Therapy Systems, Inc. (Sandy, US). The FDA issued a Cleared decision on September 28, 2023 after a review of 183 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 862.1675 - 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 Becton Dickinson Infusion Therapy Systems, Inc. devices

Submission Details

510(k) Number K230865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2023
Decision Date September 28, 2023
Days to Decision 183 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
54d slower than avg
Panel avg: 129d · This submission: 183d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 115
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K230865.
BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube
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BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes
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Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood
K230080 · Yangzhou Medline Industry, Co., Ltd. · Jul 2023
Unistik® ShieldLock, Unistik VacuFlip
K223854 · Owen Mumford, Ltd. · Jun 2023