Cleared Traditional

K250762 - ULTRASONIC PROBE UM-S20-17S (UM-S20-17S) (FDA 510(k) Clearance)

Also includes:
ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)

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

K250762 · Olympus Medical Systems Corporation · Radiology device
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Optimized for regulatory review, auditing and printing
Jul 2025
Decision
120d
Days
Class 2
Risk

K250762 is an FDA 510(k) clearance for the ULTRASONIC PROBE UM-S20-17S (UM-S20-17S). Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Olympus Medical Systems Corporation (Hachioji-Shi, JP). The FDA issued a Cleared decision on July 11, 2025 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - 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 Olympus Medical Systems Corporation devices

Submission Details

510(k) Number K250762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2025
Decision Date July 11, 2025
Days to Decision 120 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
13d slower than avg
Panel avg: 107d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ITX Transducer, Ultrasonic, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
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

Olympus Surgical Technologies of the Americas
Brenda Geary

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 - ITX Transducer, Ultrasonic, Diagnostic

All 408
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