Cleared Traditional

K211193 - BD Prevue II Peripheral Vascular Vascular Access System

K211193 is an FDA 510(k) clearance for BD Prevue II Peripheral Vascular Vascul..., manufactured by Bard Access Systems, Inc. (C.R. Bard, Inc.). The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K211193 · Bard Access Systems, Inc. (C.R. Bard, Inc.) · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2021
Decision
65d
Days
Class 2
Risk

K211193 is an FDA 510(k) clearance for the BD Prevue II Peripheral Vascular Vascular Access System. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Bard Access Systems, Inc. (C.R. Bard, Inc.) (Salt Lake Ciy,, US). The FDA issued a Cleared decision on June 25, 2021 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bard Access Systems, Inc. (C.R. Bard, Inc.) devices

FDA 510(k) Submission Details - K211193

510(k) Number K211193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2021
Decision Date June 25, 2021
Days to Decision 65 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 107d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYO Device Classification - Class 2, Special Controls

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 Radiology devices follow this clearance model.

Regulatory Peers - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 635
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K211193.
FibroScan 230
K212035 · Echosens · Jul 2021
SC1 Handheld Ultrasound Imaging System (Model: SC1)
K210468 · Fcu Co., Ltd. · Jul 2021
iSR'obot Mona Lisa 1.0
K203659 · Biobot Surgical Pte., Ltd. · Jul 2021
THD Procto Software System
K211623 · Thd Spa · Jun 2021
Palm Bladder Scanner - PBSV7.1
K210591 · Mianyang Meike Electronic Equipment Co., Ltd. · Jun 2021
Breast Volume Navigator (BVN) Model G-2000
K211098 · Metritrack, Inc. · May 2021