Cleared Traditional

bk2300 (K161960) - FDA 510(k) Clearance

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

K161960 · Bk Medical Aps · Radiology device
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Oct 2016
Decision
91d
Days
Class 2
Risk

K161960 is an FDA 510(k) clearance for the bk2300. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by Bk Medical Aps (Herlev, DK). The FDA issued a Cleared decision on October 17, 2016 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bk Medical Aps devices

Submission Details

510(k) Number K161960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2016
Decision Date October 17, 2016
Days to Decision 91 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 107d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
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 - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 632
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K161960.
Acclarix LX8 Diagnostic Ultrasound System
K162055 · Edan Instruments, Inc. · Jan 2017
ACUSON P500 Ultrasound System
K163396 · Siemens Medical Solutions USA, Inc. · Jan 2017
DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System
K162845 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Dec 2016
Voluson E6, Voluson E8, Voluson E10
K162269 · Ge Healthcare · Oct 2016
Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System
K162267 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Sep 2016
ACUSON NX2 Diagnostic Ultrasound Systems
K161787 · Siemens Medical Solutions USA, Inc. · Jul 2016