Cleared Traditional

Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS) (K231889) - FDA 510(k) Clearance

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

K231889 · Ultrasound Biotechnology (Shanghai) Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2023
Decision
177d
Days
Class 2
Risk

K231889 is an FDA 510(k) clearance for the Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ult.... Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Ultrasound Biotechnology (Shanghai) Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on December 21, 2023 after a review of 177 days - an extended review 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: 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 Ultrasound Biotechnology (Shanghai) Co., Ltd. devices

Submission Details

510(k) Number K231889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2023
Decision Date December 21, 2023
Days to Decision 177 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
70d slower than avg
Panel avg: 107d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 212
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K231889.
BD Prevue™ II Peripheral Vascular Access System
K240146 · Bard Access Systems, Inc. · Feb 2024
Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)
K233401 · Eieling Technology Limited · Feb 2024
Bladder Scanner
K230986 · Avantsonic Technology Co., Ltd. · Dec 2023
iSR`obot Mona Lisa 2.0
K232320 · Biobot Surgical Pte., Ltd. · Dec 2023
K3900 Ultrasound Imaging System
K230511 · Maui Imaging · Oct 2023
Velacur
K232459 · Sonic Incytes · Sep 2023