Cleared Traditional

K172356 - BladderScan Prime PLUS System

K172356 is an FDA 510(k) clearance for BladderScan Prime PLUS System, manufactured by Verathon Incorporated. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K172356 · Verathon Incorporated · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
43d
Days
Class 2
Risk

K172356 is an FDA 510(k) clearance for the BladderScan Prime PLUS System. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Verathon Incorporated (Bothell, US). The FDA issued a Cleared decision on September 15, 2017 after a review of 43 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 Verathon Incorporated devices

FDA 510(k) Submission Details - K172356

510(k) Number K172356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2017
Decision Date September 15, 2017
Days to Decision 43 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 107d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 642
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K172356.
CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit
K172455 · Volcano Corporation · Oct 2017
Accuro
K171594 · Rivanna Medical, LLC · Oct 2017
BR-FHUS Navigation 1.0
K171309 · Taihao Medical, Inc. · Sep 2017
FibroScan 430 Mini+
K172142 · Echosens · Sep 2017
Scanmate Flex
K171301 · Dgh Technology, Inc. · Jul 2017
Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System
K171824 · Edan Instruments, Inc. · Jul 2017