Cleared Traditional

K250020 - Diagnostic Ultrasound System (Recho R9W) (FDA 510(k) Clearance)

Also includes:

Diagnostic Ultrasound System (Recho R9) Diagnostic Ultrasound System (Recho R9 Pro) Diagnostic Ultrasound System (Recho R9 Exp) Diagnostic Ultrasound System (Recho R9S) Diagnostic Ultrasound System (Recho R9T) Diagnostic Ultrasound System (Crius R9 CV) Diagnostic Ultrasound System (Anesus R9 CV) Diagnostic Ultrasound System (Recho R9 Super) Diagnostic Ultrasound System (Recho R9 Lumi) Diagnostic Ultrasound System (Recho R CV) Diagnost

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

K250020 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Radiology device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

May 2025

Decision

136d

Days

Class 2

Risk

K250020 is an FDA 510(k) clearance for the Diagnostic Ultrasound System (Recho R9W). 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 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on May 19, 2025 after a review of 136 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 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. devices

Submission Details

510(k) Number	K250020 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 03, 2025
Decision Date	May 19, 2025
Days to Decision	136 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

29d slower than avg

Panel avg: 107d · This submission: 136d

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.